BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5131001 · Received October 6, 2015

    Report

    Report Number
    3004209178-2015-20094
    Event Type
    Malfunction
    Date Received
    October 6, 2015
    Date of Event
    April 27, 2015
    Report Date
    September 8, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_PTM_PROG, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V952224, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE WAS USING HER PATIENT PROGRAMMER TO ¿RAISE THE NUMBERS¿ AND WAS DOING THAT SLOWLY BUT IT STOPPED AT 6. THE PATIENT WAS ON PROGRAM 2 AT 6.35 AND SAW THE UPPER LIMIT ICON AND ¿IT HELPED BUT IT WAS NOT STOPPING IT.¿ THE FIRST ONE DID NOT STOP IT, THIS ONE WAS BETTER. IT WAS UNCLEAR WHAT ¿ITS NOT STOPPING IT¿ AND ¿HER FIRST ON DID NOT STOP IT¿ MEANT. THE PATIENT HAD A LOSS OF THERAPY. THE PATIENT DID NOT FEEL STIMULATION AT ALL AND THE THERAPY WAS NOT ON. THE PATIENT INCREASED TO 6.2 THEN 6.5 AND SAW THE UPPER LIMIT ICON. IT WAS RECOMMENDED THAT THE PATIENT TURN IT BACK DOWN TO 5.0 AND TRY IT AND INCREASE IT OVER THE NEXT WEEK. THE INDICATIONS FOR USER WERE URINARY DYSFUNCTION/SACRAL NERVED STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE STEPS TAKEN TO RESOLVE THE LACK OF STIMULATION WAS A CHANGE TO PROGRAM 2. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661204 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR