BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4211115 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20629
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 8, 2014
    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

    PRODUCT ID 3889-28, LOT# VA06NFS, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT, IN THE PAST MONTH, EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) NOTED AS HAVING ¿FLOWS ALL DAY LONG¿. THE PATIENT STATED THAT WHEN THEY WERE INITIALLY IMPLANTED, THEY WERE ¿GETTING SOME BENEFIT¿. THERE WERE NO KNOWN ACCIDENTS OR TRAUMAS NOTED RELATED TO THE EVENT BUT THE PATIENT STATED THAT THEY WERE STRESSED BECAUSE THEIR SPOUSE WOULD BE HOSPITALIZED FOR 6 WEEKS WITH A BLOOD INFECTION. THE PATIENT WAS ON PROGRAM 1 INITIALLY BUT ABOUT A MONTH AGO THEY STARTED TO LOSE CONTROL. THE PATIENT HAD TRIED PROGRAM 2 AND WAS NOW ON PROGRAM 3 AT ABOUT 3.2 TO 3.4. IN ADDITION, WHEN THE PATIENT CHANGED TO THAT PROGRAM LAST NIGHT THEY COULD FEEL THE ¿PRESSURE¿. THE PATIENT NOTED THAT THE DAY TIME WAS NOT AS BAD AS THE NIGHT TIME (¿NIGHT TIME IS THE WORSE¿ FOR THEM LATELY). IT WAS NOTED THAT LAST NIGHT WAS ESPECIALLY BAD FOR THEM AND WAS WEARING 2 DISPOSABLE PAIRS OF UNDERWEAR. THE PATIENT ¿WENT THROUGH¿ THEIR MATTRESS PAD AS WELL. THE PATIENT WAS ALSO TAKING ORAL MEDICATION (TOVIAZ) FOR BLADDER CONTROL AND STATED THAT IT WAS NOT HELPING THEM. THE PATIENT WAS DIAGNOSED WITH MULTIPLE SCLEROSIS (MS) AND WAS IN A WHEELCHAIR AND HOME BOUND NOW THAT THEIR SPOUSE (CAREGIVER) WAS IN THE HOSPITAL AND COULD NOT GET TRANSPORTATION TO THE DOCTOR¿S OFFICE. IT WAS ALSO NOTED THAT THE WITH THE MS DIAGNOSIS, THE PATIENT HAD LOST CONTROL OF THEIR BLADDER AND BOWELS ALTHOUGH THEIR BOWELS SEEMED TO BE DOING ¿ALRIGHT LATELY¿. THREE DAY LATER, ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT THOUGHT THEIR INS DIED. THE PATIENT HAD GONE 0-4 AND NO MATTER WHERE THEY PUT IT THEY FLOW LIKE A FAUCET. THE ISSUE HAD BEEN GOING ON FOR A COUPLE OF WEEKS. THEY HAD ¿DILIGENTLY¿ BEEN WORKING WITH THEIR PROGRAMMER, WHERE THEY STATED THAT THEY COULD START AT 1 AND GO ALL THE WAY UP WITH NO DIFFERENCE NOTED. ONCE THEY WERE FINALLY ABLE TO ¿GET THE NUMBERS¿ ON THE PROGRAMMER THEY WOULD CHANGE IT BUT IT MADE NO DIFFERENCE. THE PATIENT DID NOT DRIVE, STAND, OR WALK (PATIENT WAS IN A WHEELCHAIR) AND CONFIRMED THAT THEIR SPOUSE WAS THE CAREGIVER BUT WAS HOSPITALIZED AND COULD NOT GET IN TO SEE THEIR DOCTOR. THE PATIENT HAD CALLED THEIR HEALTHCARE PROFESSIONAL¿S (HCP) AND WAS WAITING TO HEAR BACK. OVER FOUR MONTHS LATER, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE PATIENT DIDN'T THINK HER MACHINE WAS WORKING ANYMORE. THE PATIENT HAD INCREASED STIMULATION TO A POINT WHERE SHE COULD HARDLY SIT DOWN, BUT SHE WAS STILL GETTING UP EVERY 1.5-2.5 HOURS A NIGHT. IT WASN'T THAT OFTEN DURING THE DAY. THIS HAD BEEN GOING ON FOR 2-3 MONTHS AND THE PATIENT DIDN'T REMEMBER IF IT WAS SUDDEN OR GRADUAL. THE THERAPY WAS NOT WORKING AS EXPECTED. THE PATIENT PLANNED TO CALL HER HCP (HEALTHCARE PROVIDER) TO REQUEST THE REPRESENTATIVE. OVER THREE MONTHS LATER, ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT NEEDS A REPLACEMENT BATTERY AND WAS BEING IMPLANTED (B)(6) 2014. THE EVENT CAUSE WAS DETERMINED TO BE DEPLETED BATTERY OR NOT KEEPING STIMULATION AT OPTIMAL LEVELS. NO REPROGRAMMING WAS NEEDED. IT WAS REPORTED THAT THE PATIENT WAS EDUCATED AND DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692557 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention