BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL CORD STIMULATOR

    MDR report key: 1861369 · Received October 4, 2010

    Report

    Report Number
    MW5017687
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    MEDTRONICS
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY MOTHER HAD A MEDTRONICS SPINAL CORD STIMULATOR IMPLANTED (B)(6) 2008. IT DID NOT WORK INITIALLY. SUBSEQUENTLY, SHE HAS HAD SEVERAL SURGERIES TO SHORTEN AND REPOSITION THE LEADS. HER PAIN HAS NEVER DIMINISHED AND FOR THE PAST YEAR IT HAS BEEN INCREASING. THIS DEVICE PROMISED IT WOULD HELP MANAGE HER PAIN. IT'S NOT WORKING SO, SHE IS HAVING IT REMOVED (B)(6)2010, SO ADDITIONAL DIAGNOSTIC PROCEDURES CAN BE DONE. DATES OF USE: (B)(6)2008-(B)(6)2010. DIAGNOSIS OR REASON FOR USE: TO RELIEVE CHRONIC BACK/LEG PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL CORD STIMULATOR LGW MEDTRONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other