BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4170133 · Received October 14, 2014

    Report

    Report Number
    3004209178-2014-19642
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 22, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0LM39, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS HAVING PROBLEM WITH THEIR THERAPY NOT REALLY WORKING, SHE HAD TO GO TO THE BATHROOM EVERY 2 HOURS. IT WAS NOTED THAT PRIOR TO IMPLANT PATIENT WAS GOING EVERY HOUR AND A HALF, WAS CONSTANTLY GOING BUT COULD NOT EMPTY HER BLADDER. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT AFTER IMPLANT, PATIENT¿S SYMPTOMS WERE IMPROVED BUT STARTING 3 DAYS PRIOR, SYMPTOMS WERE NOT BEING HELPED. THE PATIENT WAS CONCERNED SHE HAD CHANGED THINGS WHEN SHE FLEW TO HOUSTON AND WENT THROUGH SECURITY. IT WAS REPORTED THAT THE STIM WAS ON PROGRAM 3 AT 2.6. IT WAS SET AT 2.4 BUT SHE HAD INCREASED IT ON THE MORNING OF THIS CALL. ADDITIONAL INFORMATION RECEIVED 8 DAYS LATER THAT PATIENT HAD HER STIMULATION ON 2.2 AND A DAY OR SO AGO TURNED IT TO 3 AND MIGHT TURN IT A LITTLE BIT HIGHER". THE PATIENT WAS INCREASING STIMULATION BECAUSE SHE WAS HOPING NOT HAVE TO GO TO THE BATHROOM AS OFTEN AND SHE HAD BEEN. THE PATIENT HAD TO GET UP A COUPLE TIMES AT NIGHT". THE HEALTH CARE PROVIDER WAS HAVING THE PATIENT TAKE "CEPHALEXIN¿ IN THE MORNING RATHER THAN THE NIGHT, SO THAT SHOULD HELP. IT WAS ALSO NOTED THAT PATIENT USED A NEW SECURITY MACHINE AT THE AIRPORT. IT WAS NOTED THAT AFTER THE PATIENT WENT THROUGH THE SCANNER IT SEEMED LIKE THE SYMPTOMS WERE COMING BACK A LITTLE MORE SO PATIENT RAISED IT UP AND THAT HELPED. THE PATIENT INDICATED THAT SHE ¿APPRECIATE THE DEVICE IT¿S WONDERFUL". NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649847 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR