BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2172141 · Received June 15, 2011

    Report

    Report Number
    3004209178-2011-04474
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 23, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER EVAL OF DEVICE (METHOD UNK), PT WAS ADVISED THAT THERE WAS A LOOSE WIRE. IT WAS UNCERTAIN IF PERSON EVALUATING DEVICE WAS FROM THE HEALTH CARE PROFESSIONAL OFFICE OR A MFR'S REP. AFTER BENDING OVER AND HITTING THE DEVICE ON (B)(6) 2011 STIMULATION WAS BEING FELT IN STOMACH AS WELL AS IN THE BICYCLE SEAT AREA. PLAN WAS FOR PT TO FOLLOW-UP WITH HEALTH CARE PROFESSIONAL. ADD'L INFO IS BEING REQUESTED.

    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 LEAD: MODEL 3889, LOT# J0546213V| LEAD: MODEL 3889, LOT# J0546213V| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD033200N| EXPLANTED: