BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1080223 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04242
    Event Type
    Injury
    Date Received
    July 22, 2008
    Report Date
    June 23, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO ANOMALIES ASSOCIATED WITH THE IPG OR EXTENSION. NO SIGNIFICANT ANOMALIES WERE DISCOVERED WITH THE LEAD, THOUGH IT WAS OUT OF SPECIFICATION. IT WAS SUSPECTED THAT IT WAS CUT THROUGH DURING EXPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE INITIALLY WORKED FOR HER, THOUGH SHE FELT ACTUAL STIMULATION ONLY SOME OF THE TIME. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND AFTER UNDERGOING SEVERAL UNSUCCESSFUL REPROGRAMMING SESSIONS SHE STARTED TO EXPERIENCE PAINFUL SHOCKING SENSATIONS IN HER BACK AND DOWN HER LEG, AS WELL AS EPISODES OF OVERSTIMULATION. IMPEDANCE MEASUREMENTS WERE NORMAL. THE DEVICE WAS TURNED OFF AND SUBSEQUENTLY EXPLANTED.

    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 Required Intervention EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION MODEL 3095 LOT# NAH030396V| LEAD MODEL 3093 LOT# V008993| EXPLANTED: