BEUDAMED
    FDA Adverse Event Other Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 18491697 · Received January 10, 2024

    Report

    Report Number
    MW5150123
    Event Type
    Other
    Date Received
    January 10, 2024
    Date of Event
    January 1, 2021
    Report Date
    January 10, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A REPORTER CALLED TO SUBMIT A REPORT ABOUT HER PROCLAIM STIMULATOR NOT WORKING. SHE SAID SHE HAS TWO DEVICES IMPLANTED AND BOTH OF THEM ARE NOT WORKING THE WAY THEY ARE SUPPOSED TO. SHE SAID THE FIRST ONE WORKED FOR 3 YEARS AND STOPPED WORKING AND THE SECOND WORKED FOR 3 WEEKS AND THE WIRE BROKE, AND IT STOPPED WORKING. AS A RESULT, SHE IS NOT GETTING PAIN RELIEF. HER DOCTOR SUGGESTED FOR HER TO SEE A NEUROSURGEON AND SHE DID. SHE SAID THE NEUROSURGEON SUGGESTED TO OPEN A HOLE IN HER VERTEBRAE AND ATTACH THE LINE WITH A HOOK. SHE SAID SHE DECLINED THE SURGERY FOR FEAR OF ADDITIONAL COMPLICATIONS. REF REPORT # MW5150122.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676104 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female