BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2101720 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03428
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO THE DEVICE INTERROGATION SHOWED HIGH IMPEDANCES AND THE PT WAS UNABLE TO GET ANY THERAPY BENEFIT. THERE WAS NO KNOWN TRAUMA ASSOCIATED WITH THIS EVENT. NO X-RAYS HAD BEEN DONE. REPROGRAMMING WAS NOT EFFECTIVE IN RE-ESTABLISHING STIMULATION. A REVISION WAS PLANNED. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, 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 H0261992

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD095267N| EXPLANTED:| LEAD: MODEL 3093, LOT# V363083