Events

Recall of PRECISION SPINAL CORD STIMULATION SYSTEM - CLINICIAN PROGRAMMER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION.

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
    54000
  • Event Risk Class
    III
  • Event Initiated Date
    2007-10-10
  • 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
    Patient controllers were mislabeled with model number sc-7177 but they should have been as model number sc-5400. packaging had correct labelling but physical device had incorrect labelling.

Device

PRECISION SPINAL CORD STIMULATION SYSTEM - CLINICIAN PROGRAMMER

Manufacturer

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
  • Manufacturer Address
    VALENCIA
  • Source
    HC