Events

Recall of Device Recall iCon Patient Programmer

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
    48752
  • Event Risk Class
    Class 3
  • Event Number
    Z-2322-2008
  • Event Initiated Date
    2008-05-12
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72059
  • 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
    Stimulator, electrical, implantable, for incontinence - Product Code EZW
  • Reason
    Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. the application software is needed for a patient programmer to synchronize and bond with a neurostimulation device. without this functionality a patient programmer is not useable and can not communicate with a neurostimulation device.
  • Action
    A letter was sent to each account telling them of the issue and to let them know that Medtronic is retrieving the affected devices. Medtronic Reps were to visit affected accounts to notify them of the recall, locate the affected device and return it. Rep is to complete the reply card and fax to Medtronic Neuromodulation. If you have questions, contact your Medtronic representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Device

Device Recall iCon Patient Programmer
  • Model / Serial
    serial numbers: NJD058707N, NJD062024N, NJD063259N, and NJD063324N
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    GA, MO, NC, TX no OUS distribution
  • Product Description
    Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

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