Events

Safety Alert for STIMULATOR / NERVE LOCATOR, DISPOSABLE PULSATRON LL; IDENTIFIER: NO. CATALOG 82-62015;

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC XOMED SURGICAL PRODUCTS INC DIV MEDTRONIC INC.

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
    157
  • Date
    2000-06-19
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The above mentioned nerve locator can operate intermittently, which may result in a lack of perception of stimulus when the nervous tissue is really touched by the stimulator. this false-negative response may be interpreted as the absence of nervous tissue. the manufacturer started a removal by correspondence dated of june 19, 2000.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE DATED CORRESPONDENCE OF JUNE 19, 2000 AND THE MEDTRONIC XOMED SURGICAL PRODUCTS CHECKLIST. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY USING THE CHECKLIST. RETURN THE PRODUCT AFFECTED FOR MEDTRONIC XOMED SURGICAL PRODUCTS AT THE ADDRESS REFERRED TO. MEDTRONIC XOMED SURGICAL PRODUCTS WILL ISSUE A CREDIT OR SEND A NERVE STIMULATOR / LOCATOR FOR ANY AFFECTED PRODUCT RETURNED. WHEN YOU SEND THE AFFECTED PRODUCT, CLEARLY IDENTIFY THE EXPORT PACKAGING PARTY ON THE OUTSIDE OF THE SHIPPING PACKAGE, THE PRODUCT RETURN AUTHORIZATION NUMBER SPECIFIED IN THE NOTIFICATION LETTER AND INCLUDE A COPY OF THE CORRESPONDENCE DATE OF JUNE 19, 2000 AND THE CHECKLIST FOR RECEIPT OF THE CREDIT. FILL IN THE CHECKLIST AND FAX FOR MEDTRONIC XOMED SURGICAL PRODUCTS 1 (904) 296-2386. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH MEDTRONIC XOMED SURGICAL PRODUCTS CONSUMER SERVICE BY PHONE 1 (904) 296-9600 IN THE UNITED STATES.

Device

STIMULATOR / NERVE LOCATOR, DISPOSABLE PULSATRON LL; IDENTIFIER: NO. CATALOG 82-62015;

Manufacturer

MEDTRONIC XOMED SURGICAL PRODUCTS INC DIV MEDTRONIC INC
  • Source
    ANVSANVISA