Events

Safety Alert for INTERFACE WITH THE PATIENTS OF THE NIM2 AND NIM2XL MODELS OF THE NERVE ELECTROMYOGRAPHS / LOCATOR / STIMULATORS

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. DIVISION OF MEDTRONICS 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
    12
  • Date
    2001-03-14
  • 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 interface may not detect the existence of the nerve, resulting in irreversible damage during operation.
  • Action
    THE MANUFACTURER STARTED WITHDRAWAL ON JULY 31, 2000. HOSPITALS, CLINICS AND RELATED SURGEONS MUST CHECK THAT THEY RECEIVED MEDTRONICS NOTIFICATION. YOU MUST IDENTIFY AND REMOVE THE AFFECTED PRODUCTS FROM YOUR INVENTORY. THE AFFECTED INTERFACE UNITS CAN BE DIFFERENTIATED FROM THE STANDARD MODELS BY THE MISSING DECALCOMANY SEAL AROUND THE CABLE NEXT TO THE CONNECTION TO THE MONITOR. FOR FURTHER INFORMATION, CALL MEDTRONIC XOMED, ​​00XX1 (904) 296-9600.

Device

INTERFACE WITH THE PATIENTS OF THE NIM2 AND NIM2XL MODELS OF THE NERVE ELECTROMYOGRAPHS / LOCATOR...

Manufacturer

MEDTRONIC/ XOMED SURGICAL PRODUCTS INC. DIVISION OF MEDTRONICS INC.
  • Source
    ANVSANVISA