BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3173862 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10500
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # V786287, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS DUE TO NORMAL BATTERY DEPLETION. IT WAS NOTED THAT HOSPITALIZATION WAS NOT REQUIRED DUE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION, SAW THE ¿CALL YOUR DOCTOR¿ ICON, AND A POR (POWER ON RESET) CONDITION. IT WAS NOTED THAT THE POR WITH A TRIANGLE IN THE UPPER LEFT HAND CORNER SHOWED UP ON THE SCREEN YESTERDAY. THE PATIENT REQUESTED COMPATIBILITY GUIDELINES FOR A TENS OR OTHER EXTERNAL STIMULATION, AS THE PATIENT WOULD BE ABOUT 4 INCHES AWAY FROM THE DEVICE WHEN SHE WOULD BE USING THE TENS UNIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272881 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR