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  • Dispositivo 178
  • Fabricante 0
  • Evento 162
  • Implante 50
Retiro De Equipo (Recall) de Device Recall Synchromed II
  • Tipo de evento
    Recall
  • ID del evento
    29297
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1040-04
  • Fecha de inicio del evento
    2004-05-11
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33489
  • 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
    Pump, Infusion - Product Code FRN
  • Causa
    The opposite version serial numbers were assigned to 20ml and 40ml synchromed ii model 8637 pumps. this size-type indication is used by the programmer to identify the pump size and can cause a limitation in the useable fill volume on a 40 ml pump and could cause some confusion related to the size of a 20 ml pump which identifies itself as a 40 ml pump.
  • Acción
    The physicians have been notified via letter of the problem with the pump. Appointments will be made with the patients and a Medtronic representative to correct the implanted devices.
Retiro De Equipo (Recall) de Device Recall 8870 Software Application Card Version AAA 02
  • Tipo de evento
    Recall
  • ID del evento
    29849
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1334-04
  • Fecha de inicio del evento
    2004-08-24
  • Fecha de publicación del evento
    2004-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34649
  • 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
    Pump, Infusion, Implanted, Programmable - Product Code LKK
  • Causa
    With the model 8870 software application card versions aaa 02, bbb 04, bbc 02, and bbd 01, which is used in conjunction with the model 8840 n'vision clinician programmer, users may have mistakenly entered a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. this issue is limited to programming the synchromed and synchromed el pumps.
  • Acción
    Letters were distributed 8/24/2004 utilizing a courier with signed receipt upon delivery. The letters were signed for upon receipt at the consignee address, and the contents of the letter included a response form which can be faxed or mailed back to Medtronic. If any letters are returned as 'undeliverable', attempts will be made to telephone these consignees. A press release was issued on September 22, 2004 by Medtronic Inc. for all Version AAA 02 Model 8870 software application cards in the U.S.
Retiro De Equipo (Recall) de Device Recall Medtronic SynchroMed EL
  • Tipo de evento
    Recall
  • ID del evento
    35595
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0022-2007
  • Fecha de inicio del evento
    2006-06-06
  • Fecha de publicación del evento
    2006-10-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46457
  • 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
    Programmable implanted infusion pump - Product Code LKK
  • Causa
    The catheter access port (cap) on synchromed el pumps manufactured between march and july 1999 may detach from the main body of the pump, which can interrupt drug flow to the target site.
  • Acción
    An Urgent medical Device Recall letter was sent to healthcare providers beginning June 06, 2006. The letter describes the issue, patient risk, identifies affected devices, and provides patient Management recommendations. The letter also asks for a response card to be returned to Medtronic. Patients may contact Medtronic Neurological Patient Services at 1-800-510-6735.
Notificaciones De Seguridad De Campo acerca de SynchroMed lmplantable Infusion Pump
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    The clinician refill reference card for synchromed® implantable infusion systems that was originally distributed with the january 2011 medical device correction related to pocket fills has been updated to align with new product labeling. the january 2011 medical device correction letter provided important reminders concerning the potential for a pocket fill during a synchromed ii or synchromed el implantable drug pump refill procedure, and important patient management recommendations. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient's subcutaneous tissue, which includes the pump pocket, instead of the pump. .
Notificaciones De Seguridad De Campo acerca de SynchroMed lmplantable Infusion Pump
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    The synchromed priming bolus function is intended to quickly advance drug from the pump reservoir to the catheter tip to allow for therapy initiation while the patient remains under medical supervision. although drug is not intended to be delivered to the cerebrospinal fluid (csf) during the priming bolus, mixing of the drug and non-drug (sterile water/csf) fluids occurs at the high infusion rates used during a priming bolus. mixing results in the unintended delivery of drug prior to the end of the programmed bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. patients will receive unintended drug at a high rate of infusion in the csf during the priming bolus, and a period of reduced concentration of drug will occur following the priming bolus. .
Notificaciones De Seguridad De Campo acerca de Synchromed II
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/files/2012/11/SynchroMed.pdf
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    Based on data collected from medtronic's implantable systems performance registry, the overall failure rate for a synchromed ii pump during the 78 months after installation is 2.4% if used to administer approved drugs, and 7.0% if used for administration of unapproved drugs. the use of unapproved drugs may cause temporary or permanent downtime of the pump motor, which have been reported as loss of therapy or change of therapy.
Notificaciones De Seguridad De Campo acerca de SynchroMed II Programmable Implantable Infusion Pump
  • Tipo de evento
    Field Safety Notice
  • Fecha de publicación del evento
    2013-01-08
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2013/08/01/vazno-obavestenje-o-medicinskom-sredstvu-synchromed-ii-programmable-implantable-infusion-pump-model8637/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    Within the synchromed pump, feedthroughs are components that provide an electrically insulated path for current to flow from the electroniccircuitry to the motor. an electrical short can occur when ions from the drug solution and humidity permeate through the drug pathway tubing inside the pump and interact with the feedthrough over time. an electrical short circuit in a feedthrough may present as a motorstall or low battery reset/alarm and leadto a loss of or reduction in therapy which may result in the return of underlying symptoms and/or withdrawal symptoms. synchromed pump internal feedthrough shorts can lead to a loss of or reduction in therapy which may result in a return of underlying symptoms and/or withdrawal symptoms.Patients receiving intrathecal baclofen therapy are at risk for baclofen withdrawal syndrome, which can lead to a life threatening condition if not promptly and effectively treated.Surgical revision to replace or remove the pumps may be required for patients with pumps experiencing repeated motor stalls, low battery resets (with or without safe state), or a premature elective replacement indicator.
Notificaciones De Seguridad De Campo acerca de SynchroMed II Programmable Implantable Infusion Pump
  • Tipo de evento
    Field Safety Notice
  • Fecha de publicación del evento
    2013-01-08
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2013/08/01/vazno-obavestenje-o-medicinskom-sredstvu-synchromed-ii-programmable-implantable-infusion-pump-model8637-2/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    This letter provides important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the synchromed®implantable infusion pump. this unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.
Notificaciones De Seguridad De Campo acerca de SynchroMed II Programmable Implantable Infusion Pump
  • Tipo de evento
    Field Safety Notice
  • Fecha de publicación del evento
    2013-01-08
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2013/08/01/vazno-obavestenje-o-medicinskom-sredstvu-synchromed-ii-programmable-implantable-infusion-pump/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    The clinician refill reference card for synchromed® implantable infusion systems that was originally distributed with the january 2011 medical device correction related to pocket fills has been updated to align with new product labeling. the january 2011 medical device correction letter provided important reminders concerning the potential for a pocket fill during a synchromed ii or synchromed el implantable drug pump refill procedure, and important patient management recommendations. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient's subcutaneous tissue, which includes the pump pocket, instead of the pump.
Notificaciones De Seguridad De Campo acerca de SynchroMed II Programmable Implantable Infusion Pump
  • Tipo de evento
    Field Safety Notice
  • Fecha de publicación del evento
    2012-11-19
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2012/11/19/важно-обавештење-о-медицинском-средс/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    The overall failure rate for the synchromed ii pump during the 78 months after installation is 2.4% if used to administer approved drugs, and 7.0% if used to administer unapproved drugs. the use of unapproved drugs may cause temporary or permanent downtime of the pump motor, which have been reported as a loss of therapy or a change in therapy. changes to therapy can cause serious injury and / or death.
Retiro De Equipo O Alerta De Seguridad para Lots CS3643 and CS3663 of the Model 8551 Filling Kit ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-04-29
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Removal from the market of certain batches of the product "Model 8551 filling kit used with Synchromed implantable infusion pumps", manufactured by Medtronic Inc, USA.
Retiro De Equipo O Alerta De Seguridad para Software Model 8870 card used in the N'VisionTM 8...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-01-10
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Update of the Model 8870 software card used in the N'VisionTM 8840 Medical Programmer and the instructions for use of the SynchroMed® II Implantable Infusion Systems, manufactured by Medtronic Inc, USA.
Retiro De Equipo O Alerta De Seguridad para N'Vision medical programmer for the Synchromed II...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2012-03-22
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possible appearance on the screen of the N'Vision medical programmer, manufactured by Medtronic Inc., of an incorrect replacement date for SynchroMed® II pumps that may result in the pump reaching the end of its life before replacement .
Retiro De Equipo O Alerta De Seguridad para Synchromed II® implantable pumps and Synchromed EL
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-06-11
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility of certain problems with the Synchromed II® and Synchromed EL implantable pumps, manufactured by Medtronic Inc., USA.
Retiro De Equipo O Alerta De Seguridad para SynchroMed II implantable infusion pumps
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2015-06-23
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Information on SynchroMed II Implantable Infusion Pumps, manufactured by Medtronic Inc., USA
Retiro De Equipo O Alerta De Seguridad para "SynchroMed® II" drug infusion pumps, not implanted, ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-03-07
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Withdrawal from the market of certain "SynchroMed® II" infusion pumps, not implanted, models 8637-20 and 8637-40, manufactured by Medtronic Inc., USA.
Retiro De Equipo O Alerta De Seguridad para SynchroMed II implantable pump
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-04-04
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Risk of overinfusion with the SynchroMed II implantable pump, manufactured by Medtronic, Inc., USA.
Retiro De Equipo O Alerta De Seguridad para SynchroMed II Implantable Pumps, Models 8637-20 and 8...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-11-08
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Update of the information regarding the risk of overinfusion with the SynchroMed II implantable pump, manufactured by Medtronic, Inc., USA.
Retiro De Equipo O Alerta De Seguridad para Implantable infusion systems SynchroMed® II and Synch...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2012-11-20
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility of increasing the risk of stops in the motor of the SynchroMed® implantable infusion pump due to the use of non-approved pharmacological formulations for this pump
Retiro De Equipo O Alerta De Seguridad para Software application card for the N'Vision medica...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-10-10
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Updating model 8870 of the software application card of the N'Vision medical programmer to correct problems affecting the Synchromed II pumps and devices for deep brain, spinal cord and peripheral nerve stimulation.
Retiro De Equipo O Alerta De Seguridad para "SynchroMed® II" implantable drug infusion pumps, mod...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2015-05-06
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Withdrawal from the market of certain implantable drug infusion pumps "SynchroMed® II", and recommendations for the follow-up of patients implanted with them, due to a possible interruption in the operation of the audible alarm.
Retiro De Equipo O Alerta De Seguridad para Synchromed® II implantable drug infusion pump, models...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-11-27
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Safety warning related to the lower reliability of Synchromed II pumps when used with non-approved drugs and communication of a design change to reduce the possibility of an engine shutdown.
Retiro De Equipo O Alerta De Seguridad para Synchromed® II implantable drug infusion pump, models...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-12-20
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • URL de la fuente del evento
    N/A
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Removal of unused Synchromed® II implantable drug infusion pumps from the market, with an expiration date equal to or prior to December 31, 2018, and replacement by pumps with an improved motor design.
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  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 065 12 17 000
  • Fecha de inicio del evento
    2017-12-19
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11899
  • Notas / Alertas
    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
    Medtronic has received approval for a design change to the synchromed ii implantable drug infusion pump. this design change of the motor decreases the potential for intermittent or permanent motor stall which can cause loss of therapy. all synchromed ii pumps are now being manufactured and distributed with this change.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 082 03 14 002
  • Fecha de inicio del evento
    2016-10-23
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10108
  • Notas / Alertas
    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
    Medtronic detected an upward shift in reports of occurrence for overinfusion.
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