BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1191123 · Received September 26, 2008

    Report

    Report Number
    3004209178-2008-06161
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 29, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY A MONTH AGO THE PATIENT WAS WEARING A HEARING AID SPEAKER AT CHURCH. THE TRANSMITTER BOX WAS SITTING NEXT TO HIM ON THE PEW WHEN HE RECEIVED A SHOCK. SINCE THEN HE HAS BEEN SHOCKED INTERMITTENTLY IN THE GROIN, WHICH CAUSED LEG WEAKNESS AND PAIN. HE LOST THERAPEUTIC EFFECT. FURTHER INFORMATION 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 43 YR Required Intervention IMPLANTED:| LEAD: MODEL 3889| EXPLANTED:| EXTENSION: MODEL 3095| IMPLANTED:| PROGRAMMER: MODEL 3031A| EXPLANTED: