BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5661476 · Received May 17, 2016

    Report

    Report Number
    3004209178-2016-09691
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Report Date
    May 17, 2016
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# V872659, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND HAD A CHANGE IN STIMULATION WITH POSITION. THE PATIENT TRIED SEVERAL PROGRAMS WITH NO SUCCESS. THE PATIENT WOULD LEAVE IT ON FOR ABOUT 3 DAYS AND THEN FOUND THAT IT DIDN'T WORK AND CHANGED THE PROGRAM. THE PATIENT WOULD HAVE AN APPOINTMENT ON (B)(6) 2012. THE CONSUMER FURTHER REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND A LOSS OF BLADDER CONTROL. THE PATIENT'S SYMPTOMS OCCURRED MOSTLY AT NIGHT AND OCCURRED EVERY 4TH DAY OR SO. THE PATIENT USUALLY HAD ABOUT AN 80% SUCCESS RATE WITH THE THERAPY. THE PATIENT SEEM TO HAVE ISSUES EVERY SO OFTEN AT NIGHT AND HAD NOT MADE ANY ADJUSTMENTS WITH THE LEVEL OF STIMULATION RECENTLY. THE PATIENT THOUGHT THEY HAD TRIED MOST OF THEIR PROGRAMS AND SO FAR PROGRAM 2 SEEMED TO BE THE BEST. THE PATIENT WAS UNCERTAIN IF THEY HAD TRIED PROGRAM 4 YET OR NOT. THE CONSUMER LATER REPORTED THAT THE PATIENT EXPERIENCED A LOSS OR CHANGE OF THERAPY. THE IMPLANT DID NOT WORK FOR THE PATIENT, SO THEY HAD HAD THEIR DEVICE TURNED OFF FOR THE PAST 2 YEARS SINCE 2014. WHEN THE IMPLANT WAS ON, IT ANNOYED THE PATIENT MORE THAN IT HELPED. THE IMPLANT DID INITIALLY HELP WITH THEIR BLADDER SYMPTOMS AND THEN STOPPED WORKING. THE PATIENT WANTED TO HAVE THE DEVICE REMOVED. THE INDICATION FOR USE FOR THIS PATIENT WAS URINARY DYSFUNCTION/SACRAL NERVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316338 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1