Events

Safety Alert for NOTE: THIS MESSAGE IS BEING SENT TO UPDATE INFORMATION FROM AN ALREADY ALREADY PUBLISHED. IMPLANTABLE MARCAPASSO ENRHYTHM P1501DR MEDTRONIC. Registro Anvisa 10339190253. Check affected models at: http://portal.anvisa.gov.br/wps/wcm/connect/9af3ad80418176aeab4cfbc509124714/Produtosasafedados.pdf?MOD=AJPERES.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Comercial Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1005
  • Date
    2010-02-22
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    Medtronic Inc. (headquarters of Medtronic Commercial Ltd.) received 62 reports - out of a total of approximately 110,000 devices worldwide - which indicated that the device interrogation battery voltage was below the stipulated voltage for the device to display the notification of selective substitution indicator (ERI). The measurement of a lower voltage has provoked some questions and, in some situations, it was reason to explain the pacemaker. If the previously mentioned software update is not performed, there is a potential risk of loss of function in a small percentage of devices (less than 0.08% six years after implantation). According to the company, this risk should be eliminated with the software update. Medtronic also identified a faster (than battery) voltage reduction due to the lithium depletion at a slightly faster rate. This subject has not yet been observed in the clinical setting and is not expected to occur within the next 4 years (9 years after implantation). If the previously mentioned software update is not performed, the potential risk of therapeutic loss during or near the ERI / RRT warning may be verified in a reduced number of devices. According to the company, updating the software will eliminate this risk, as it will change the ERI / RRT warning criteria. #### UPDATE (01/11/2011): The company reported (file # 902973 / 11-7) that the action was finalized at the end of 2010 (software update) and presented updated patient control recommendations . Such information can be viewed at http://portal.anvisa.gov.br/wps/wcm/connect/acaf128048ee03f3980c9c466b74119d/Alerta_1005_Orientacoes_Complementares.pdf?MOD=AJPERES.
  • Reason
    Possibility of the equipment battery losing its charge ahead of schedule.
  • Action
    The company said it is providing an upgrade of the equipment software to address the reported problem. Once the new software version is available, affected customers will be notified by the company for guidance on how to proceed. It is recommended that physicians continue to support the replacement of the device in the ERI / RRT notice. At this time, no further action is recommended, reprogramming or changing the frequency of follow-up.

Device

NOTE: THIS MESSAGE IS BEING SENT TO UPDATE INFORMATION FROM AN ALREADY ALREADY PUBLISHED. IMPLANT...

Manufacturer

Medtronic Comercial Ltda.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA