BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4956857 · Received July 31, 2015

    Report

    Report Number
    3004209178-2015-14427
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 14, 2011
    Report Date
    July 27, 2015
    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
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3889-28, LOT# V113835, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE FOR 2 YEARS WITH THEIR CONDITION WAS GETTING WORSE. THE HEALTH CARE PROVIDER (HCP) HAD TRIED MANY SETTINGS AND IT DIDN'T HELP AT ALL, AS ONE SETTING SEEMED THE SAME AS ANOTHER. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND A LOSS OF BLADDER CONTROL. THE PATIENT WOKE UP SOAKED AT NIGHT. THE PATIENT GOT NO WARNING AND BY THE TIME THEY GOT TO THE BATHROOM IT WAS TOO LATE. PART OF THE ISSUE WAS THAT THEY ALSO HAD PERIPHERAL NEUROPATHY IN THEIR FEET AND IT TOOK A WHILE TO WALK TO THE BATHROOM. AT NIGHT WAS TERRIBLE AND THE PATIENT WOKE UP VERY WET AND COULDN'T MAKE IT TO THE BATHROOM, PERHAPS DUE TO THE SLOWNESS OF THEIR FEET. THE PATIENT HAD HAD SHOTS AROUND THE URETHRA TO HELP HOLD UP THEIR BLADDER WITH NO SIGNS OF HELP. NOW THEY WANTED TO PUT BOTOX IN THE PATIENT'S BLADDER, BUT THAT WAS EVERY 6 MONTHS AS IT WEARS OFF AND THE PATIENT DIDN'T THINK THAT WOULD BE HEALTHY. THE PATIENT COULDN'T CATHETERIZE THEMSELVES. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE PATIENT WOULD ADJUST THE AMPLITUDE AND TRACK THEIR SYMPTOMS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NO LONGER USING THEIR DEVICE BECAUSE IT WASN¿T WORKING. THE PATIENT¿S HCP HAD TAKEN A LOOK AT THE DEVICE AND THE SIGNALS WERE REACHING THE BLADDER, BUT THE BLADDER WASN¿T EMPTYING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499930 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Other