BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1202899 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06678
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    April 16, 2008
    Report Date
    September 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO ANOMALIES FOUND FOR THE NEUROSTIMULATOR. THERE WAS NO DEVICE FAILURE. THE CONNECTOR BLOCK, INSULATION COATING AND TITANIUM CAN WERE SCRATCHED. THE BATTERY WAS EXPANDED. A STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR. IT WAS FUNCTIONING FINE. FINAL DEVICE ANALYSIS REVEALED NO ANOMALIES FOUND FOR THE LEAD EXTENSION. THERE WAS NO DEVICE FAILURE. THE CONTINUITY WAS ACCEPTABLE. THE DISTAL AND PROXIMAL ENDS WERE INTACT AND UNDAMAGED. THE OUTER INSULATION WAS INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S SYMPTOMS RETURNED. THE PT'S NEUROLOGIST DID A NERVE CONDUCTION STUDY AND EMG OVER THE NEUROSTIMULATOR SITE. THE PT HEARD A LOUD NOISE AND THE NEUROSTIMULATOR STOPPED WORKING. A LEAD IMPEDANCE MEASUREMENT SHOWED NO OPEN CIRCUITS. THE NEUROSTIMULATOR AND LEAD EXTENSION WERE REPLACED. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention LEAD MODEL 3093 LOT# J0542921V| EXPLANTED| PROGRAMMER MODEL 3031A LOT# NGM021015P| EXPLANTED| EXTENSION MODEL 3095 LOT# NAH022928V| IMPLANTED| IMPLANTED