Events

Safety Alert for External Defibrillators, Medtronic Brand, Lifepak 12 Models (ANVISA Register 10339190080) and Lifepak 20 (ANVISA Record 10339190171) manufactured between October 2005 and February 2006.

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

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
    827
  • Date
    2006-04-25
  • 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
    UTVIG / NUVIG / ANVISA has followed the actions of the company since the voluntary notification of Medtronic Comercial Ltda. More information can be obtained through the mail tecnovigilancia@anvisa.gov.br
  • Reason
    These devices contain a therapy connector that may have one or more pins that do not meet design specifications. the connector has 10 metal pins that are used as low-voltage control lines for cable connection checking, battery and power control, and transfer functions. if any of these pins have a lower depth than specified, the pin will be susceptible to excessive stress, possibly breakage, leading to a certain inoperative function. a weak connection may delay or inhibit the transport of therapy. information on the action as well as the list of affected series numbers can be found at http://www.Medtronic-ers.Com/notices/12-20.
  • Action
    Medtronic Comercial Ltda informs that it is contacting each place where the products were distributed in order to schedule a visit to correct the affected equipment. This action will not generate any cost to the organization, simply making the equipment available at the time of inspection. Update on 06/26/2006: Medtronic Commercial Ltd. informs that all defibrillators, manufactured between October 2005 and February 2006, have been inspected and corrected.

Device

External Defibrillators, Medtronic Brand, Lifepak 12 Models (ANVISA Register 10339190080) and Lif...

Manufacturer

Medtronic Physio Control
  • Source
    ANVSANVISA