Events

Recall of Medtronic Lead Kit

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

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
    36164
  • Event Risk Class
    Class 3
  • Event Number
    Z-1537-06
  • Event Initiated Date
    2006-08-02
  • Event Date Posted
    2006-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48110
  • 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
    Spinal cord Stimulation lead - Product Code LGW
  • Reason
    Model 3777 standard octad lead (lot v009545) and model 3778 compact octad lead (lot v009546) were mispackaged. the result of this error is that lead kits labeled 3777 lot v009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot v009546 may contain a 3777 standard-spaced lead. the result of this error is an overall increase or decrease of 14 mm in the electrode coverage.
  • Action
    Medtronic representatives retrieved non-implanted devices. An Urgent Medical Device Recall letter was sent to physicians to describe the issue and patient management information.

Device

Medtronic Lead Kit
  • Model / Serial
    Model 3778, Lot V009546
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution --- including states of CA, GA, KY, LA, and TX.
  • Product Description
    Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.
  • Manufacturer
    Medtronic Neurological

Manufacturer

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