Events

Safety Alert for Product: Pacemaker Cardiac Resynchronization Therapy (M-CRT) InSync III. Model (s): 8042, 8042B and 8042U. Anvisa Registry n ° 10339190158.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC COMERCIAL LTDA; Medtronic Inc; Medtronic BV; Medtronic Europe SA.

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
    1748
  • Date
    2015-11-20
  • 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
    Unexpected high battery impedance may result in the inability of the battery to provide sufficient electrical current, impacting the operation of the device. Twelve (12) of the 30 devices (devices that reported failure) reported unexpected loss of pacing. The other 18 devices exhibited some inappropriate behavior, including premature elective replacement (ERI) indication, significant fluctuations in estimates of remaining longevity and imprecise electrode impedances. As of October 27, 2015, the events associated with this problem occurred on devices with an implant period of 53 months or more. Medtronic received a patient death report, for which it is possible, but not confirmed, that this problem may have been a contributing factor. If rhythm capture is compromised, some patients may experience a return of symptoms of heart failure due to loss of biventricular rhythm. In cases involving pacemaker dependent patients, a loss of rhythm capture can result in severe injury or death.
  • Reason
    Unexpected high battery impedance, which can result in the inability of the battery to provide sufficient electrical current and negatively impact the operation of the device.
  • Action
    The company is sending alert messages to its customers with instructions on how to proceed. Each patient requires a unique clinical consideration. Recommendations for patients with a CRT InSync III pacemaker are as follows: (1) Prophylactic replacement of the device in non-pacemaker dependent patients is not recommended; (2) For pacer dependent patients, clinicians should consider the risks and benefits of replacing the pacemaker in order to minimize this problem case by case - the estimated mortality risk per patient for this problem (0.007% to 0.02%) is comparable to the estimated mortality risk per patient for complications associated with premature and incremental device replacement (0.005%); (3) Maintain routine patient follow-up according to standard practice and advise patients to seek medical help immediately in case of new or unexpected symptoms. Company code for field action: FA682.

Device

Product: Pacemaker Cardiac Resynchronization Therapy (M-CRT) InSync III. Model (s): 8042, 8042B a...

Manufacturer

MEDTRONIC COMERCIAL LTDA; Medtronic Inc; Medtronic BV; Medtronic Europe SA
  • 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