BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2182305 · Received July 11, 2011

    Report

    Report Number
    3007566237-2011-05294
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED STIMULATION "SHOOTING INTO THE BOWELS," FOLLOWING REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR. BOWEL MOVEMENTS ALSO CAUSED A FEELING OF BEING "ELECTROCUTED." THE DEVICE WAS PLACED VERY SUPERFICIALLY AND THE PT WAS ABLE TO FEEL THE SCREWS IN THE DEVICE. THE PT WAS SCHEDULED TO HAVE SURGERY TO FIX, OR REPOSITION, THE DEVICE. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. ADD'L INFO WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR IMPLANTABLE NEUROSTIMULATOR: MODEL 3058| PROGRAMMER: MODEL 3037 LOT# NJD114244N| LOT# NJY155467| IMPLANTED:| LEAD: MODEL 3093 LOT# V514854| EXPLANTED:| EXPLANTED:| IMPLANTED: