BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3102226 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07414
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 19, 2013
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3889-28, LOT# V969911, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT HAD PROBLEMS GETTING THE PROGRAMMER AND IMPLANT TO SYNCHRONIZE CONSISTENTLY AND WANTED TO ADJUST IT BECAUSE SHE WAS GETTING PAIN AND IT WAS A ¿VERY UNCOMFORTABLE SETTING.¿ THE PATIENT STATED THAT THE IMPLANT ¿MOVED AROUND¿ AND HAD ¿MOVED UP GRADUALLY¿ FORM WHERE IT WAS ORIGINALLY. THE PATIENT THOUGHT IT MAY BE BECAUSE OF THE WAY ¿SHE TURNED WHEN SHE SLEPT.¿ THE PATIENT HAD ¿TROUBLE WITH HER IMPLANT ALL THE TIME.¿ THE PATIENT WAS ABLE TO SYNC BRIEFLY WITH THE ANTENNA OVER THE DEVICE BUT QUICKLY LOST CONNECTION. THE PATIENT TRIED MULTIPLE TIMES WITH AND WITHOUT THE ANTENNA BUT WAS UNABLE TO GET A CONNECTION. THE PATIENT PLANNED ON CALLING HER HEALTH CARE PROVIDER (HCP) ON THE MONDAY AFTER THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT THAT HER DEVICE HAD "MOVED UP" SINCE IMPLANT. THE PATIENT STATED THAT THE DEVICE "SEEMED TO HAVE IMBEDDED" SO SHE WAS UNABLE TO FEEL IT AS MUCH AND IT "SEEMED" TO HAVE "MOVED UP TOWARDS HER WAIST." THE PATIENT DID NOT FEEL ANY PAIN AT THE POCKET SITE BUT WAS CONCERNED THAT IT HAD MOVED AND MAY HAVE CAUSED HER THERAPY TO "FEEL DIFFERENT." THE PATIENT HAD A RETURN OF SYMPTOMS IN THE WEEK AND HALF PRIOR TO THE REPORT. THE PATIENT FELT SHE DID NOT HAVE THE CONTROL SHE USED TO AND THE STIMULATION WAS NOT FEELING AS STRONG AS IT ONCE DID. THE PATIENT LIKED THE SETTING SHE WAS ON AND ADJUSTED STIMULATION UP SO THAT SHE FELT STIMULATION STRONGER BUT SHE WAS NOT GETTING THE CONTROL. THE PATIENT DRANK "A LOT OF WATER" DUE TO THE ORAL MEDICATION SHE TOOK. THERE WAS NO KNOWN RELATED ACCIDENT OR INCIDENT. THE PATIENT HAD NOT SEEN HER HEALTH CARE PROVIDER (HCP) IN "ABOUT ONE YEAR." THE PATIENT HAD AN APPOINTMENT SCHEDULED ON (B)(6) 2013 TO REMOVE A "PESSARY" AND PLANNED TO HAVE HER DEVICE CHECKED THEN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203487 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1