Events

Safety Alert for EXTERNAL TEMPORARY MARCAPASSO 5388. Anvisa Registry n ° 10339190199.

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
    1034
  • Date
    2010-11-05
  • 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
    According to the manufacturer of the product (Medtronic), the cause of the problem is the high contact power on the device's electronic circuit board. No patient injuries were observed by the company resulting from the problem in question. The company announces the closure of the field action with the following numbers: Number of clients informed: 67 - Number of units affected: 137 units affected, Number of units traded on customers: 98 units, Number of units in inventory (unlicensed): 12 units, Number of units not located on customers: 27 units. The 98 units exchanged on the customers and the 12 non-marketed units were re-exported to the factory.
  • Reason
    Pacer may not turn on or off unexpectedly.
  • Action
    According to the product registration holder (Medtronic Commercial Ltda.), If there is loss of control of rate, performance, sensitivity, or power - non-low battery loss - the device must be disconnected and returned to Medtronic for repair or replacement. exchange.

Device

EXTERNAL TEMPORARY MARCAPASSO 5388. Anvisa Registry n ° 10339190199.

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