BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4162047 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19415
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V926179, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE YEAR PRIOR TO THE REPORT THE PATIENT HAD A REVISION SURGERY. THE PATIENT HAD LOST A LOT OF WEIGHT AND THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BECAME LOOSE AND STARTED MOVING AROUND. THE DEVICE WAS FLOPPING AROUND IN THEIR BUTTOCKS. WHEN THEY WOULD LAY DOWN IT FELT LIKE A ROCK AND IT WOULD HIT THEIR NERVE AND THEY COULD BARELY MOVE THEIR LEG. THE REVISION SURGERY FIXED THE ISSUE, BUT THE PATIENT STILL HAD PAIN FROM THE INCISION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643946 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention