BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 17530235 · Received August 12, 2023

    Report

    Report Number
    MW5137155
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    January 20, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    LGW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC NEUROMODULATION (BSN) RECEIVED INFORMATION ABOUT AN EVENT THAT WOULD HAVE BEEN REPORTABLE UNDER 21 CFR 803, MEDICAL DEVICE REPORTING WITHIN OUR COMPLAINT SYSTEM. HOWEVER, THE ISSUE REPORTED WAS RELATED TO IMPLANTED SPINAL CORD STIMULATOR LEADS MANUFACTURED BY MEDTRONIC. A REPORT WAS RECEIVED THAT A PATIENT IMPLANTED WITH MEDTRONIC LEADS UNDERWENT A LEAD REVISION DUE TO INEFFECTIVE THERAPY. THE PHYSICIAN SUSPECTED THAT ONE OF THE MEDTRONIC LEADS WAS FRACTURED. THE PHYSICIAN EXPLANTED THE MEDTRONIC LEADS AND IMPLANTED THE PATIENT WITH TWO NEW BOSTON SCIENTIFIC NEUROMODULATION LEADS. THE MEDTRONIC LEADS WERE NOT RETURNED TO BOSTON SCIENTIFIC NEUROMODULATION. N/A. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727752 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown