BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR ELECTRICAL IMPLANTABLE FOR INCONTINENCE

    MDR report key: 3318744 · Received August 27, 2013

    Report

    Report Number
    MW5031656
    Event Type
    Injury
    Date Received
    August 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    August 26, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    EZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BURNING IN THE AREA OF THE IMPLANTATION OF THE INTERSTIM II (B)(4) THERAPY AND PERSISTENT PAIN LOWER BACK AND ABDOMEN. NO RELIEF OF PAIN HAVE BEEN DEALING WITH THIS PAIN SINCE (B)(6) 2013 THE DAY OF THE IMPLANT. TOLD MY DOCTOR ON SEVERAL OCCASIONS AND WAS IN THE PROCESS OF HAVING IT REMOVED IN (B)(6,) BUT DOCTOR (B)(6) (OB/GYN) "TALKED ME INTO" KEEPING IT A WHILE LONGER. I HAVE SINCE MOVED FROM (B)(6). AND HAVE AN APPOINTMENT WITH DR. (B)(6), A UROLOGIST AT (B)(6). TO TALK ABOUT REMOVAL OF THE DEVICE. IT HAS NOT BROUGHT MUCH RELIEF AS THE PAIN IS UNBEARABLE AT TIMES AND FOR THREE WEEKS HAVE NOT TURNED IT ON DUE TO BURNING AND HURTING IN MY BACK AND ABDOMEN AND BURNING IN THE AREA OF THE STIMULATOR IMPLANTATION. THIS PRODUCT SEEMS TO BE DEFECTIVE, AS I CALLED MEDTRONIC A WEEK AGO AND EXPLAINED MY SYMPTOMS AND WHAT THE DEVICE DOES WHEN I HAVE IT TURNED ON AND OFF. MEDTRONIC INC. INTERSTIM II (B)(4) STIMULATOR, ELECTRONIC IMPLANTABLE FOR INCONTINENCE: IMPLANTABLE FOR SACRAL NERVE STIMULATION REGULATION NUMBER (B)(4), PMA NUMBER N970004, SUPPLEMENT NUMBER S144 APPROVED (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417986 STIMULATOR ELECTRICAL IMPLANTABLE FOR INCONTINENCE STIMULATOR ELECTRICAL IMPLANTABLE FOR INCONTINENCE EZW MEDTRONIC, INC. 3058 S144

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R