BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1952036 · Received January 4, 2011

    Report

    Report Number
    3004209178-2011-00007
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 29, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE "TAPPING" STIMULATION SENSATION WAS AGGRAVATING HIS TAILBONE. THE PT WAS ABLE TO SWITCH BETWEEN GROUPS AND ACTIVATED PROGRAM 1 AT 3.6 VOLTS. F/U INFO RECEIVED INDICATED THAT THE PATIENT MET WITH HIS PHYSICIAN AND THE COMPANY REP FOR THE PROBLEM. THE PT'S DEVICE WAS SUCCESSFULLY REPROGRAMMED AND HE WAS NO LONGER HAVING PROBLEMS WITH HIS DEVICE. SUBSEQUENT INFO RECEIVED REPORTED THAT THE PATIENT'S DEVICE HAD "MALFUNCTIONED". HE EXPERIENCED PAIN FROM HIS IMPLANT FROM THE TIME IT WAS IMPLANTED AND THAT IT NEVER REALLY WORKED. IF ADD'L INFO IS RECEIVED, A F/U REPORT WILL BE SENT.

    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 66 YR EXPLANTED:| LEAD: MODEL 3093, LOT# V465540| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD107279N