Events

Recall of Device Recall Interstim for Urinary Control

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Neuromodulation.

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
    44740
  • Event Risk Class
    Class 2
  • Event Number
    Z-0040-2008
  • Event Initiated Date
    2007-06-25
  • Event Date Posted
    2007-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64346
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implantable Neurostimulator for Urinary Control. - Product Code EZW
  • Reason
    Software issue may cause false low battery alert to be displayed when interrogating an interstim implantable neurostimulator (model 3023) with an n'vision clinician programmer (model 8840), or with an inter stim icon patient programmer (model 3037).
  • Action
    Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient management for the two issues. The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.

Device

Device Recall Interstim for Urinary Control
  • Model / Serial
    All serial numbers within these catalog/model numbers are affected (Model 3023, Catalog Number 8870MMB01 and 8870NNB01)
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and the Netherlands.
  • Product Description
    Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Manufacturer Address
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA