BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2081044 · Received April 14, 2011

    Report

    Report Number
    3004209178-2011-02824
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 5, 2011
    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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS SHOCKING AND JOLTING. THE PT WAS IN THE KITCHEN AND HAD SHOCKING AND JOLTING THROUGHOUT THE ENTIRE BODY. THE STIMULATOR WAS TURNED OFF, AND THE SHOCKING STOPPED ABOUT 30 MINUTES LATER. THE RPTR STATED THE STIMULATOR HAD BEEN TURNED OFF FOR 3 MONTHS. IT WAS UNCLEAR IF THE STIMULATOR WAS ON WHEN THE SHOCKING STARTED OR IF IT WAS STILL OFF. THE STIMULATOR SITE WAS SORE, AND THE PT CALLED 911. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR IMPLANTED:| PROGRAMMER: MODEL 3037, LOT # NJD067745N| LEAD: MODEL 3093, LOT # V100937| EXPLANTED: