BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3912953 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12506
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 309328, LOT# B0951230K, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USE OF A PERSONAL LAPTOP ON EITHER KNEES OR TABLE RESULTED IN THE DESIRE TO ¿OPEN BOWELS¿ WITHIN TEN MINUTES OF USE. NO DIAGNOSTIC OR TROUBLESHOOTING WAS PERFORMED. THE PATIENT¿S STATUS AT THE TIME OF THE EVENT WAS ALIVE AND NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391463 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR