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  • Dispositivo 27
  • Fabricante 92
  • Evento 253
  • Implante 4
Retiro De Equipo (Recall) de St Jude Medical Ellipse VR CD1377-36C Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Ellipse DR CD2277-36 Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Ellipse VR CD1377-36QC Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Ellipse DR CD2377-36QC Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Ellipse DR CD2377-36 Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Ellipse VR CD1277-36 Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Ellipse VR CD1377-36 Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Ellipse DR CD2377-36Q Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Ellipse VR CD1277-36Q Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Ellipse VR CD1377-36Q Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Ellipse DR CD2277-36Q Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Ellipse DR CD2377-36C Implantable Defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    17202
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices., as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value., this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock., there have been no serious injuries or patient deaths reported to st. jude medical as a result of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de St Jude Medical Merlin @ Home
  • Tipo de evento
    Recall
  • ID del evento
    17899
  • Fecha de inicio del evento
    2014-12-24
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Medical New Zealand Limited, C/- Healthcare Logistics, 54 Carbine Road, Mt Wellington, Auckland 1641
  • Causa
    Low incidence of back up operation in some implanted st. jude medical devices with radio frequency (rf) capability. this may occur as a result of a merlin@home transmitter initiating an implanted device software reset., this issue can only occur when the patient is being actively monitored by a merlin@home rf bedside transmitter.
  • Acción
    Software to be upgraded
Retiro De Equipo (Recall) de VALITUDE X4 CRT-P U128
  • Tipo de evento
    Recall
  • ID del evento
    22363
  • Fecha de inicio del evento
    2017-12-15
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • Causa
    The manufacturer has received reports of intermittent oversensing of the minute ventilation (mv) sensor signal with certain pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). mv sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. this mv behavior may occur with any manufacturer's pacing lead system, but the manufacturer has determined it to be more likely for affected pacemakers using medtronic or abbott/st. jude (abbott) leads implanted in either the right atrium (ra) or right ventricle (rv).
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de PROPONENT MRI SR Pacemaker L210
  • Tipo de evento
    Recall
  • ID del evento
    22363
  • Fecha de inicio del evento
    2017-12-15
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • Causa
    The manufacturer has received reports of intermittent oversensing of the minute ventilation (mv) sensor signal with certain pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). mv sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. this mv behavior may occur with any manufacturer's pacing lead system, but the manufacturer has determined it to be more likely for affected pacemakers using medtronic or abbott/st. jude (abbott) leads implanted in either the right atrium (ra) or right ventricle (rv).
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de VISIONIST CRT-P U225
  • Tipo de evento
    Recall
  • ID del evento
    22363
  • Fecha de inicio del evento
    2017-12-15
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • Causa
    The manufacturer has received reports of intermittent oversensing of the minute ventilation (mv) sensor signal with certain pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). mv sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. this mv behavior may occur with any manufacturer's pacing lead system, but the manufacturer has determined it to be more likely for affected pacemakers using medtronic or abbott/st. jude (abbott) leads implanted in either the right atrium (ra) or right ventricle (rv).
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de ACCOLADE MRI SR Pacemaker L310
  • Tipo de evento
    Recall
  • ID del evento
    22363
  • Fecha de inicio del evento
    2017-12-15
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • Causa
    The manufacturer has received reports of intermittent oversensing of the minute ventilation (mv) sensor signal with certain pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). mv sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. this mv behavior may occur with any manufacturer's pacing lead system, but the manufacturer has determined it to be more likely for affected pacemakers using medtronic or abbott/st. jude (abbott) leads implanted in either the right atrium (ra) or right ventricle (rv).
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de Device Recall ACCOLADE MRI EL DR Pacemaker
  • Tipo de evento
    Recall
  • ID del evento
    78787
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0359-2018
  • Fecha de inicio del evento
    2017-12-07
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160476
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
  • Causa
    Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
  • Acción
    On December 19, 2017 the firm sent a letter to all their medical consignees stating the following: December 2017 Dear Doctor, Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV). Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems. Root Cause Investigation The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A. Engineering analysis and
Retiro De Equipo (Recall) de Device Recall Merlinhome RF Remote Monitoring Transmitter, Model EX...
  • Tipo de evento
    Recall
  • ID del evento
    70066
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0949-2015
  • Fecha de inicio del evento
    2014-12-18
  • Fecha de publicación del evento
    2015-01-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132201
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Pulse generator, permanent, implantable - Product Code NVZ
  • Causa
    Transmitter may initiate a software reset resulting in backup operation in some implanted st. jude medical radio frequency (rf) enabled implantable cardioverter assura, unify assura, and quadra assura icds and assurity and allure pacemakers.
  • Acción
    The firm, St. Jude Medical, sent an "Important Medical Device Correction" Dear Doctor Letter dated 12/18/14 to customers to inform them that the Merlin@home transmitters may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Defibrillators (ICDs) and Pacemakers. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contact their local St. Jude Medical representative or St. Jude Medical's Technical Services Department at 1-800-722-3774.
Retiro De Equipo (Recall) de Device Recall TactiSys Quartz Pack, PN004 400
  • Tipo de evento
    Recall
  • ID del evento
    70490
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1284-2015
  • Fecha de inicio del evento
    2014-11-25
  • Fecha de publicación del evento
    2015-03-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133892
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
  • Causa
    A configuration update needs to be done on tactisys to appropriately recognize all tacticath catheters.
  • Acción
    St. Jude Medical sent a Service Bulletin to inform of a TactiSys Configuration File update that needs to be performed. A technical service personnel will visit each consignee and performed the software change on-site. For questions about this Service Bulletin, contact Technical Support (ETechsupport@sjm.com).
Retiro De Equipo (Recall) de Device Recall Optisure HV lead
  • Tipo de evento
    Recall
  • ID del evento
    72569
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0660-2016
  • Fecha de inicio del evento
    2015-11-03
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141537
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
  • Causa
    Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the svc shock coil.
  • Acción
    An Important Medical Device Advisory letter was sent to doctors on 11/3/15 to inform them of the recall by St. Jude Medical. The letter informs the doctors that St. Jude Medical identified that during the manufacturing process of a limited number of Optisure leads, a trim technique to remove excess medical adhesive around the SVC shock coil may have introduced damage to the leads insulation. The letter provides the doctors with the recommendations for patients with a potentially impacted Optisure lead connected to a device with Dynamic TX technology and for patients implanted with a potentially impacted Optisure lead connected to a device without DynamicTx technology. Doctors with questions about the advisory are instructed to contact their local Sales Representative or St. Jude Medical Technical Services at (800) 722-3774.
Retiro De Equipo (Recall) de Device Recall VALITUDE CRTP Pacemaker
  • Tipo de evento
    Recall
  • ID del evento
    78787
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0360-2018
  • Fecha de inicio del evento
    2017-12-07
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160477
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
  • Causa
    Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
  • Acción
    On December 19, 2017 the firm sent a letter to all their medical consignees stating the following: December 2017 Dear Doctor, Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV). Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems. Root Cause Investigation The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A. Engineering analysis and
Retiro De Equipo (Recall) de Device Recall VALITUDE X4 CRTP Pacemaker
  • Tipo de evento
    Recall
  • ID del evento
    78787
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0361-2018
  • Fecha de inicio del evento
    2017-12-07
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160478
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
  • Causa
    Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
  • Acción
    On December 19, 2017 the firm sent a letter to all their medical consignees stating the following: December 2017 Dear Doctor, Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV). Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems. Root Cause Investigation The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A. Engineering analysis and
Retiro De Equipo (Recall) de Device Recall ALTRUA 2 SR Pacemaker
  • Tipo de evento
    Recall
  • ID del evento
    78787
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0362-2018
  • Fecha de inicio del evento
    2017-12-07
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160480
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
  • Causa
    Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
  • Acción
    On December 19, 2017 the firm sent a letter to all their medical consignees stating the following: December 2017 Dear Doctor, Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV). Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems. Root Cause Investigation The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A. Engineering analysis and
Retiro De Equipo (Recall) de Device Recall ALTRUA 2 DR Pacemaker
  • Tipo de evento
    Recall
  • ID del evento
    78787
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0363-2018
  • Fecha de inicio del evento
    2017-12-07
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160493
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
  • Causa
    Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
  • Acción
    On December 19, 2017 the firm sent a letter to all their medical consignees stating the following: December 2017 Dear Doctor, Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV). Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems. Root Cause Investigation The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A. Engineering analysis and
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