BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5493558 · Received March 10, 2016

    Report

    Report Number
    3004209178-2016-04337
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    February 13, 2015
    Report Date
    February 17, 2016
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# VA0Q4MK, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND WAS NOT GETTING THE RESULTS THEY WANTED. THE TRIAL WAS DONE ON (B)(6) 2015 AND THE RESULTS WERE ENCOURAGING. THE IMPLANT SURGERY WAS DONE ON (B)(6) 2015 AND THE RESULTS WERE DISAPPOINTING. THE PATIENT WAS STILL GETTING UP 7 TIMES A NIGHT AND PRIOR TO IMPLANT IT WAS ABOUT 7 TIMES A NIGHT. THE PATIENT HAD HAD A COUPLE OF DAYS IT WAS DOWN TO 4 OR 5. DURING THE TRIAL THE PATIENT WAS GETTING UP BETWEEN 4 AND 7 TIMES A NIGHT. THE PATIENT STARTED WITH STIMULATION AT 0.9V, INCREASED TO 1.1V ON (B)(6) 2015, AND INCREASED TO 1.3V ON (B)(6) 2015. THE HEALTH CARE PROVIDER (HCP) TOLD THEM NOT TO GO ABOVE 6.0V. THE PATIENT WANTED TO KNOW HOW OFTEN THEY COULD ADJUST STIMULATION AND IF THEY SHOULD TURN STIMULATION OFF DURING THE DAY. IT WAS LATER REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HCP OR MANUFACTURER REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2015. THE PATIENT EXPERIENCED A LOSS OR CHANGE OF THERAPY. THE THERAPY HADN'T WORKED VERY WELL OR WORKED AT ALL FOR THE PATIENT BECAUSE THEY STILL HAD TO GET UP AN AVERAGE OF 8 TIMES A NIGHT. THE PATIENT RECORDED THE PROGRAM CHANGES AND RESULTS OF THEIR THERAPY USAGE. SINCE IMPLANT THE PATIENT GOT UP 5 TO 10 TIMES PER NIGHT. THE PATIENT铠MANAGING HCP WAS AWARE OF THIS AND TOLD THE PATIENT THEIR BLADDER WAS IRRITATED AND THAT MIGHT BE WHY. EACH TIME THE PATIENT RECEIVED "RCG" TREATMENT THEY INFORMED THE NURSE THAT THEIR DEVICE WAS NOT WORKING. THE PATIENT ALSO INFORMED THEIR HCP WHEN HAVING CYSTOSCOPIES AND FOLLOW-UP VISITS. THE PATIENT HAD APPOINTMENTS ON (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2016, (B)(6) 2016, AND (B)(6) 2016. THE PATIENT TRIED VARIOUS PROGRAMS WITH DIFFERENT INTENSITY. THE PATIENT TRIED RAISING THE INTENSITY EXTRA HIGH AND REDUCING THE LEVEL TO SEE IF THAT WOULD HELP. THE PATIENT MET WITH THEIR MANUFACTURER REPRESENTATIVE AT THEIR HCP'S OFFICE ON (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, AND (B)(6) 2015. THE MANUFACTURER REPRESENTATIVE COMBINED PROGRAMS AND THE RESULTS WERE WORSE. THE PATIENT TURNED THE DEVICE TO THE OFF POSITION AT DIFFERENT TIMES FOR SEVERAL DAYS AND RESTARTED THE PROGRAM WITHOUT ANY IMPROVEMENT. THE PATIENT'S DEVICE HAD BEEN OFF SINCE (B)(6) 2016. THE PATIENT WAS WONDERING ABOUT HAVING THE DEVICE REMOVED. THE PATIENT WAS TOLD REMOVAL OF THE DEVICE COULD CAUSE NERVE DAMAGE AND THE PATIENT WAS NOT INFORMED THAT THIS COULD BE A POSSIBILITY IF THE DEVICE WOULD BE REMOVED. THE PATIENT PUT THE DEVICE IN OUT OF DESPERATION FROM GETTING UP NUMEROUS TIMES AT NIGHT WITHOUT ANY SLEEP. THE PATIENT WAS TOLD IF THIS DID NOT WORK IT COULD BE EASILY REMOVED. THE PATIENT WANTED TO KNOW IF THERE WERE ANY NEW DEVELOPMENTS OF CORRECTIONS TO THE DEVICE TO HELP THEIR SITUATION. THE PATIENT MENTIONED HAVING BLADDER CANCER AND THEY HAD SURGERY TO REMOVE THE CANCER 2 WEEKS AGO. THE INDICATIONS FOR USE FOR THIS PATIENT WERE URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150444 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR