BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1190326 · Received October 6, 2008

    Report

    Report Number
    3004209178-2008-06352
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    March 3, 2008
    Report Date
    September 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO ANOMALIES FOUND FOR THE IMPLANTABLE NEUROSTIMULATOR. THERE WAS NO DEVICE FAILURE. THERE WAS FOREIGN MATERIAL IN THE CONNECTOR PORT. THE INSULATION COATING WAS SCRATCHED. IT PASSED AN AUTOMATED CONSOLE TEST. FINAL DEVICE ANALYSIS FOR A 3093 LEAD REVEALED NO SIGNIFICANT ANOMALIES. NO FAILURE WAS DETECTED BUT THE PRODUCT WAS OUT OF SPECIFICATION. THE LEAD WAS CUT THROUGH WHICH WAS SUSPECTED EXPLANT DAMAGE. ALL MULTIPLE CONDUCTOR WIRES WERE CUT. THE DISTAL AND PROXIMAL ENDS WERE INTACT AND UNDAMAGED. THE LEAD BODY AND INSULATION WERE CUT THROUGH. SUSPECTED BODY FLUIDS WERE IN THE LEAD WHICH HAD NO IMPACT ON THE LEAD'S PERFORMANCE. FINAL DEVICE ANALYSIS FOR THE OTHER LEAD REVEALED NO SIGNIFICANT ANOMALIES. NO FAILURE WAS DETECTED BUT THE PRODUCT WAS OUT OF SPECIFICATION. THE LEAD WAS CUT THROUGH WHICH WAS SUSPECTED EXPLANT DAMAGE. ALL MULTIPLE CONDUCTOR WIRES WERE CUT. THE DISTAL END WAS INTACT AND UNDAMAGED. THE PROXIMAL END WAS NOT RETURNED. THE LEAD BODY AND INSULATION WERE CUT THROUGH. SUSPECTED BODY FLUIDS WERE IN THE LEAD WHICH HAD NO IMPACT ON THE LEAD'S PERFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT LEG PAIN. THE IMPLANTABLE NEUROSTIMULATOR AND LEADS WERE EXPLANTED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention EXPLANTED| PROGRAMMER MODEL 3037 LOT# NJD023026N| LEAD MODEL 3093 LOT# UNK IMPLANTED| EXPLANTED| LEAD MODEL 3093 LOT# UNK IMPLANTED