Events

Alerte De Sécurité sur EXTERNAL TEMPORARY MARCAPASSO 5388. Anvisa Registry n ° 10339190199.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Medtronic Comercial Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1034
  • Date
    2010-11-05
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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