BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1061476 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03221
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH AN INTERSTIM DEVICE EXPERIENCED SHOCKING SENSATIONS. THE PT WAS AT THE COURT HOUSE AND NOTIFIED SECURITY THAT SHE HAD AN IPG IMPLANTED. SECURITY USED A WAND AND WENT OVER THE DEVICE WITH IT MULTIPLE TIMES, WHICH RESULTED IN SHOCKING SENSATIONS. THE PT FELT HER TEETH CLENCH TOGETHER AND HER FOOT JOLTED. SHE ALSO FELT A HIT IN THE HEAD AND SUBSEQUENTLY VOMITED. SHE ALSO FEELS LIKE SHE HAS "CIGARETTE BURNS ALL OVER HER BACK". FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    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 EXTENSION MODEL 3095| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 3031A| EXPLANTED:| IMPLANTED: