BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3484174 · Received November 22, 2013

    Report

    Report Number
    3004209178-2013-21316
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Report Date
    November 19, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 889-28, LOT# V840299, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THE PATIENT WAS REFERRING TO THE PATIENT PROGRAMMER BATTERIES AND NOT THE IMPLANTABLE NEUROSTIMULATOR BATTERY WHEN IT WAS STATED THE "BATTERY WAS LOW AGAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER THE PATIENT HAD THEIR BATTERY REPLACED IT WAS STILL NOT WORKING LIKE IT SHOULD BE. IT WAS STATED THE PROGRAMMER WAS CONNECTED TO IT THE DAY PRIOR TO REPORT AND IT SAID THE BATTERY WAS LOW AGAIN. IT WAS NOTED THEY DID NOT THINK THE NEW BATTERY WAS DOING ANY BETTER THAN THEIR OLD BATTERY. REPORTEDLY, THE PATIENT HAD SEEN THEIR HEALTHCARE PROVIDER SEVERAL TIMES AND HAD THE PROGRAMMING CHANGED. IT WAS NOTED, THEY MEANT THE HEALTHCARE PROVIDER WOULD INCREASE THE STIMULATION UNTIL THEY COULD FEEL IT AND THEN TURNED IT DOWN 0.1 TO 0.2 VOLTS. IT WAS NOTED THE PATIENT ONLY FELT STIMULATION WHEN THE HEALTHCARE PROVIDER ADJUSTS IT. THE PATIENT INCREASED ON PROGRAM 4 FROM 2.1 VOLTS TO 2.3 VOLTS AND THEY WERE FEELING IT IN THE VAGINA AREA. IT WAS STATED, THE PATIENT FELT STIMULATION THE DAY PRIOR TO REPORT WHEN THEY INCREASED FROM 1.8 VOLTS TO 2.1 VOLTS BUT THEN THE NIGHT PRIOR TO REPORT THEY DIDN¿T FEEL STIMULATION. IT WAS STATED, "ACTUALLY THE WETTEST SHE'S EVER BEEN WHEN SHE GOT UP THIS MORNING." THE PATIENT¿S PROGRAM WAS SWITCHED TO PROGRAM 1 AND INCREASED FROM 2.3 VOLTS TO 2.8 VOLTS AND THEY WERE FEELING STIMULATION BUT IT WAS NOT TOO STRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610831 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR