Events

Safety Alert for Trade name: POCKET ADAPTER EXTENSION ADAPTER. ANVISA registry number: 10339190354. Class of risk: IV. Affected model (s): 64001 and 64002

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
    1966
  • Date
    2016-06-21
  • 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
    #### UPDATED ON 08/23/2017, the company submitted completion report of the field action proving the action of reinforcing the instructions for use of the product.
  • Reason
    This letter reports recent results from the review of the returned product, medtronic neuromodulation pocket dynamic adapter (dbs) with high impedance reporting, and reinforces specific device labeling for pocket adaptor manipulation and integrity during implant procedures. this applies to the pocket adaptor models 64001 and 64002 that can be used with the following implantable neurostimulators: activa® pc (model 37601) and activa® rc (model 37612).
  • Action
    Field Action FA724 Recommendations for Users and Patients: The current labeling for system manipulation during implantation is described in the implant manuals. To minimize the possibility of a connector wire breakage, follow the instructions in the DBS Pocket Adapter System Implant Manual as described below to ensure that the adapter wire is not bent severely or bent at the time of implantation. The complete implant manual can be found on the product packaging. Implanting the Pocket Adapter with the Neurostimulator: 1. Place the Pocket Adapter behind the neurostimulator. Wrap the adapter wire and excess extender wire behind the adapter, making sure the wires do not bend too tightly. Also, perform a thorough inspection of the integrity of the system by checking proper electrode impedances before closing the as described in the Activa® PC Model 37601 Implant Manual.

Device

Trade name: POCKET ADAPTER EXTENSION ADAPTER. ANVISA registry number: 10339190354. Class of risk:...

Manufacturer

MEDTRONIC COMERCIAL LTDA
  • Source
    ANVSANVISA