BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2061807 · Received April 4, 2011

    Report

    Report Number
    3004209178-2011-02528
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING EXPOSURE TO A THEFT DEFECTOR OR SECURITY GATE, THE PATIENT EXPERIENCED NO STIMULATION WHILE STIMULATION WAS TURNED ON. IT APPEARED THE PATIENT HAD REACHED UPPER STIMULATION LIMITS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR PROGRAMMER: MODEL 3031A, LOT# NGM016600P| EXPLANTED:| LEAD: MODEL 3889, LOT# J0444044V| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH017324V| IMPLANTED:| IMPLANTED: