BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN

    MDR report key: 17527957 · Received August 12, 2023

    Report

    Report Number
    MW5134888
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    January 12, 2015
    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 ON (B)(6) 2014 THAT WOULD HAVE BEEN REPORTABLE UNDER 21 CFR 803, MEDICAL DEVICE REPORTING WITHIN OUR COMPLAINT SYSTEM. THE INFORMATION RECEIVED STATED THAT THE PATIENT'S MEDTRONIC IPG WAS REPLACED DUE TO ISSUES WITH THE IPG. (B)(4). 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
    2244810 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown