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.
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).
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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).
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
Notas adicionales en la data
Acción
Abbott Security Note (St. Jude Medical) regarding the withdrawal and use of some models of the 8-Pin Electrode for Infinity ™ System for Deep Brain Stimulation (DBS)
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
Notas adicionales en la data
Acción
Abbott's safety note regarding the implantable pulse generator (IPG) NM of St. Jude Medical
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
Notas adicionales en la data
Acción
Abbott's safety note regarding the implantable pulse generator (IPG) NM of St. Jude Medical
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
St. jude medical received reports of therapy degradation associated with a small number of brio ipgs at a very limited number of hospitals. an analysis of returned devices found that fluid had intruded into the ipg header assembly leading to diminished or loss of therapy. septum damage, which can occur during implant, was found in a majority of the explanted devices and can contribute to fluid intrusion into the ipg header assembly. we are taking a proactive approach by issuing a voluntarily field corrective action for the brio ipg and implementing improvements to the product.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notas adicionales en la data
Report Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158781
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Availability of new pacemaker firmware (a type of software) that is intended to address the risk of unauthorized access to st. jude pacemakers that utilize radio frequency (rf) communications (i.E., accent™/ anthem™, accent mri™/ accent st™, assurity™/ allure™ and assurity mri™). this firmware update provides an additional layer of security against unauthorized access to these devices that further reduces the potential for a successful cybersecurity attack.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
St. jude medical has received reports of inability to communicate or recharge 78 eon mini ipgs and 1 brio ipg. in the cases reported, the duration between recharges became progressively shorter until the ipg failed to charge or there was a sudden loss of power which resulted in device replacement. after thorough analysis we determined that weld failures within the internal battery of the ipg caused these reports.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Premature battery depletion with implantable cardioverter defibrillator.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Potential insulation damage at the interface of the termination sleeve and svc shock coil in optisure™ dual coil defibrillation leads.