BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2831315 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10231
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 15, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V735309, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3093-28, LOT# V718483, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE PATIENT EXPERIENCED NORMAL BATTERY DEPLETION ON BOTH SIDES. THE PATIENT'S LEFT LEAD WAS REPLACED IN ADDITION TO THIS DUE TO 'MINOR MIGRATION.' THE PATIENT HAD AN 'UNEVENTFUL REVISION' AND WAS DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. HER PATIENT PROGRAMMER DISPLAYED THE "CALL YOUR DOCTOR" ICON AND A POWER ON RESET (POR) CONDITION WAS NOTED. IT WAS REPORTED THE PATIENT'S LEFT IMPLANT HAD BEEN ACTING UP FOR ABOUT A WEEK OR MORE. THE PATIENT HAD NOT HAD MEDICAL TESTS OR PROCEDURES, NOR HAD SHE RECENTLY BEEN EXPOSED TO HIGH LEVELS OF ELECTROMAGNETIC INTERFERENCE AS SHE TYPICALLY STAYED AT HOME EXCEPT FOR DOCTOR'S APPOINTMENTS. ADDITIONAL INFORMATION RECEIVED 2 DAYS LATER REPORTED THE PATIENT'S LEFT STIMULATOR SHOWED AN END OF SERVICE (EOS) MESSAGE; BATTERY DEPLETION APPEARED TO BE NORMAL. IMPEDANCE TEST SHOWED GREATER THAN 4000 OHMS ON SOME BIPOLAR PAIRS. WHEN TESTED AS 1.6 VOLTS ALL PAIRS EXCEPT C-1 WERE GREATER THAN 4000 OHMS. IT WAS NOTED THE PATIENT HAD NOT FELT STIMULATION FOR ABOUT A MONTH AND SHE EXPERIENCED A RETURN OF RETENTION SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1