BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1923229 · Received November 9, 2010

    Report

    Report Number
    3004209178-2010-09147
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 20, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED OFF WHEN THE PT WALKED THROUGH A THEFT DETECTOR OR SECURITY GATE SYSTEM. THE PT TRIED TO TURN THE INS ON, AND THEN EXPERIENCED OVERSTIMULATION AND SHOCKING FROM ONE INS. THE PT WAS UNABLE TO TURN THE INS OFF WITH THE PT PROGRAMMER AND RECEIVED A POWER ON RESET MESSAGE. THE CONTROL MAGNET WAS NOT WORKING ALSO. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM002533P| LEAD: MODEL 3093, LOT# J0316144V| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH009282N| IMPLANTED: