BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1120747 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04964
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    August 29, 2007
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    AN X-RAY INDICATED IMPROPER PLACEMENT OF THE ELECTRODE. SYMPTOMS WERE NOT REPORTED. THE PHYSICIAN DID A PERCUTANEOUS NERVE EVAL ON THE OPPOSITE SIDE OF THE IMPLANTED DEVICE AND RECEIVED AN EXCELLENT RESPONSE FROM THE PT. A NEW LEAD AND IPG WERE PLACED AND THE OLD DEVICE SYSTEM WAS REMOVED. THE PT IMPROVED DRAMATICALLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention EXPLANTED| LEAD MODEL 3889