BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1097526 · Received July 25, 2008

    Report

    Report Number
    6000032-2008-04244
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    January 4, 2005
    Report Date
    January 20, 2005
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STIMULATOR, EXTENSION AND LEAD WERE RETURNED FOR ANALYSIS. THERE WAS NO ANOMALY FOUND DURING ANALYSIS OF THE GENERATOR AND EXTENSION. THE LEAD WAS OK, BUT CUT THROUGH (SUSPECT EXPLANT DAMAGE). THIS REPORT IS BEING FILED WHICH COVERS A TWO YR TIME PERIOD FROM 2005 TO 2007 FOR PREVIOUSLY UNREPORTED MEDICAL DEVICE REPORTS FOR MEDTRONIC GASTROLOGICAL AND UROLOGICAL (MGU) PRODUCT COMPLAINT REPORTS. THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 47 UNREPORTED MALFUNCTION EVENTS FOR MODEL 3023 AND 2 UNREPORTED MALFUNCTION EVENTS FOR MODEL 3095; ALL PRODUCT CODE EZW). THIS TOTAL INCLUDES THE EVENT DESCRIBED IN THIS REPORT. (SEE THE ATTACHED SUMMARY REPORT FOR A LISTING OF ALL EVENTS).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS EXPERIENCING SHOCKING IN THE LEFT TOES. THE PT WAS TOUCHING OTHER AND TRANSMITTING SHOCKS. THE DEVICE WAS REMOVED. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO, MED REL 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| EXPLANTED| EXTENSION MODEL 3095 LOT # NAH016012V| IMPLANTED| IMPLANTED| LEAD MODEL 3889 LOT # J0443895V| EXPLANTED| EXTENSION MODEL 3095 LOT # NAH016012V| LEAD MODEL 3889 LOT # J0443895V| IMPLANTED| IMPLANTED| EXPLANTED