BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3242266 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12135
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006-05-09 EXPLANTED: PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE IMPLANT, THE PATIENT¿S STIMULATION TURNED OFF BY ITSELF THREE TIMES. IT WAS STATED THAT IF THE PATIENT HAD STIMULATION ON, WATCHED WHAT SHE ATE, AND TOOK HER MEDICATION SHE HAD GREAT CONTROL OF HER INCONTINENCE. IN CERTAIN POSITIONS (LYING OR SITTING DOWN), THE PATIENT WOULD LOSE CONTROL OF HER URINE. IT WAS NOTED THAT AT TIMES, THE PATIENT MAY NOT FEEL STIMULATION, BUT COULD IT WAS AT ¿FULL SPEED¿ AT OTHER TIMES. OVERALL, THE PATIENT FELT STIMULATION WAS WORKING FOR HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342708 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1