BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3133678 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08305
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 8, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 093-28, LOT# V794135, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. AN APPOINTMENT ON (B)(6) 2013 WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. DISPLAY SHOWED "CALL YOUR DOCTOR" ICON; THERE WAS A POR (POWER ON RESET) CONDITION. REGARDING WHEN THE MESSAGE APPEARED, IT WAS NOTED THAT THE PATIENT HAD ATRIAL DEFIBRILATION YESTERDAY. STIM WAS ON DURING PROCEDURE. THE PATIENT HAD TRIED TO USE INS LAST NIGHT AND GOT MESSAGE. THE PATIENT WAS LEAVING OUT OF TOWN TOMORROW THROUGH THE WEEKEND AND WOULD BE WITHOUT STIM IF HE COULD NOT CLEAR POR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234288 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR