BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2181464 · Received July 5, 2011

    Report

    Report Number
    3004209178-2011-05060
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 8, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) THE PT FELT NO STIMULATION SENSATION AND WAS RETAINING URINE DESPITE TRYING ALL PROGRAMS TO THE MAXIMUM LIMIT. THE LEAD AND NEW INS HAD FUNCTIONED WELL DURING TESTING WITH "EXCELLENT PARAMETERS" DURING THE INS REPLACEMENT, BUT THEN STOPPED FUNCTIONING. IT WAS INDICATED THAT THE PROBLEM WAS WITH THE LEAD. SURGICAL INTERVENTION HAD NOT YET OCCURRED. THERE WAS NO INJURY TO THE PT. 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 II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR LEAD: MODEL 3093, LOT# V048428| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, (B)(4)