BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2182201 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05177
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    August 1, 2008
    Report Date
    June 13, 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 THE PT EXPERIENCED STIMULATION IN THE WRONG LOCATION. SINCE THE DEVICE WAS IMPLANTED, THE PT HAD AN UNCOMFORTABLE STIMULATION IN THE LEG, DOWN TO THE HEEL. THE MFR REP ATTEMPTED TO REPROGRAM THE DEVICE THREE TIMES, IN 2009. THE PT TURNED THE DEVICE OFF ON (B)(6) 2009, BUT THE STIMULATION WAS STILL FELT. THERE WERE NO FALLS OR TRAUMA EXPERIENCED BY THE PT. THE PT NEVER RECEIVED RELIEF FROM THE DEVICE AND WAS CONTEMPLATING THE REMOVAL OF THE DEVICE SYSTEM. IT WAS LATER REPORTED THAT THE PT DID NOT FOLLOW UP WITH THE PHYSICIAN, FOLLOWING THE THREE REPROGRAMMING SESSIONS ((B)(6) PREVIOUS). THE PT WAS IN PAIN. THE PT WAS INSTRUCTED TO CONTACT THE PHYSICIAN. ADD'L INFO WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR IMPLANTED:| LEAD: MODEL 3889, LOT# V121978| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD072474N