BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3250762 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12380
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377860, LOT# V020196, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER DEVICE REMOVED THREE DAYS AGO BECAUSE IT WAS NOT HELPING WITH SOME PAIN AND BECAUSE OF NEUROLOGICAL ISSUES. IT WAS NOTED THAT THE PATIENT HAD HAD A COUPLE OF MINI-STROKES, HAD MS (MULTIPLE SCLEROSIS), THERE WERE SOME ¿OTHER THINGS¿ GOING ON IN HER BRAIN, AND THE PATIENT¿S PHYSICIAN COULD NOT DO MRI¿S BECAUSE OF THE DEVICE/THERAPY. WHILE THE DEVICE HELPED WITH PAIN IN THE PATIENT¿S BACK, IT NEVER HELPED WITH HER UPPER BACK PAIN. IT WAS INDICATED THAT THE ¿BIGGEST REASON WAS THE NEUROLOGICAL REASONS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353325 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention