BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4280835 · Received November 26, 2014

    Report

    Report Number
    3004209178-2014-22234
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Report Date
    November 6, 2014
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, (B)(4) SERIAL# (B)(4) IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V072260, SERIAL# IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD TO USE THEIR DSMO MEDICATION TO CALM THEIR BLADDER. THE PATIENT HAD TRIED PROGRAMS ONE, TWO, AND WAS CURRENTLY ON PROGRAM THREE. THE PATIENT HAD INCREASED STIMULATION BECAUSE THEY COULD NOT FEEL IT. THEY WANTED TO TRY PROGRAM FOUR. WHILE ON THE CALL, THE PATIENT SWITCHED TO PROGRAM FOUR AND ADJUSTED TO A LEVEL THAT THEY COULD ¿SOMEWHAT¿ FEEL STIMULATION AT. IT WAS REPORTED THE PATIENT HAD GREATER THAN FIFTY PERCENT SYMPTOM REDUCTION. THE PATIENT WAS SEEN TWICE FOR REPROGRAMMING AND CHANGED TO PROGRAM THREE AND THEN PROGRAM FOUR. THE PATIENT DID NOT GET RELIEF FROM ANY LEVEL OF EITHER PROGRAM. MEDICATION DID HELP. THE PATIENT EXPERIENCED EXTREME BLADDER SPASMS, FREQUENCY, AND URGENCY. THE PATIENT HAD A SUDDEN LOSS OF THERAPEUTIC EFFECT. THE PATIENT DID NOT LOSE STIMULATION SENSATION. THE PATIENT¿S SYMPTOMS WERE ONGOING. THE PATIENT¿S BATTERY WAS DUE TO RUN OUT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769103 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR