BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3942215 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13198
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# VA0KLLU, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND THIS HAPPENED ONLY 1 TIME. SINCE IMPLANT THERAPY HAD BEEN GOOD BUT LAST NIGHT ONE TIME THE PATIENT HAD THE RETURN OF SYMPTOMS OF AN ACCIDENT. IT WAS NOTED THAT THE PATIENT HAD NOTICED SINCE IMPLANT THAT EVERYDAY MOVEMENT MIGHT HAVE AN EFFECT ON STIMULATION PERCEPTION. THE PATIENT¿S TRAINING ON THE PATIENT PROGRAMMER WAS INEFFECTIVE BECAUSE THE PATIENT WAS STILL UNDER THE EFFECTS OF ANESTHESIA. IT WAS REPORTED THAT THE PATIENT WAS REALLY OUT OF IT AND THEY TRIED SHOWING THEM BUT SAID THEY COULD TRY AGAIN LATER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. AN APPOINTMENT DATE OF (B)(6) 2014 WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STOPPED FEELING STIMULATION FOUR DAYS PRIOR TO CALL. THE PATIENT HAD INCREASED STIMULATION AS HIGH AS IT CAN GO ON ALL FOUR PROGRAMS AND DID NOT FEEL STIMULATION. THE PATIENT ALSO HAD A SUDDEN LOSS OF THERAPEUTIC EFFECT AND BLADDER CONTROL. THERE WERE NO FALLS OR TRAUMA ASSOCIATED WITH THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419168 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR