BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL CORD STIMULATOR

    MDR report key: 3820552 · Received May 15, 2014

    Report

    Report Number
    MW5036156
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A BOSTON SCIENTIFIC SPINAL CORD STIMULATION SYSTEM MODEL NUMBER SC-1110-02. IT WASN'T RIGHT FROM THE BEGINNING AND GOT WORSE. WHEN I USED IT, I WOULD PEE ON MYSELF. WHEN I WENT TO CHARGE IT, IT BURNED REALLY REALLY BAD, FROM THE BOX IN MY HIP ALL THE WAY TO THE END OF THE LEADS IN MY BACK. THE LAST SIX MONTHS WERE MISERABLE. FINALLY GOT THEM TO REMOVED IT ON (B)(6) 2014. THIS WAS THE SECOND ONE I HAVE HAD. FIRST WORKED GREAT. THEY HAD TO REMOVE IT DUE TO A BAD FALL DOWN SOME STEPS, SO I KNOW A GOOD ONE FROM A BAD AND THE ONE THEY REPLACED WAS DEFECTIVE. PLUS I SUFFER FROM REALLY BAD MIGRAINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289784 SPINAL CORD STIMULATOR NONE LGW BOSTON SCIENTIFIC SC-1110-02

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other