Events

Recall of SIGMA PACEMAKER SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25157
  • Event Risk Class
    II
  • Event Initiated Date
    1999-09-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Manufacturer's robotics process problem as extra energy was applied to the connector anchoring mechanism.

Device

SIGMA PACEMAKER SYSTEM
  • Model / Serial
    Model Catalog: SVVI103 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SD 200 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SVVI (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SVDD303 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SVDD300 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SVDD 300 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSVI103 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSVI100 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR306 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR303 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR300 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR203 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR200 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR 306 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR 303 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR 300 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SSR 200 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SS103 (Lot serial: ALL SERIAL NUMBERS); Model C
  • Product Description
    SIGMA PACEMAKER SYSTEM
  • Manufacturer
    MEDTRONIC INC.

Manufacturer

MEDTRONIC INC.
  • Manufacturer Address
    MINNEAPOLIS
  • Source
    HC