BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3904524 · Received July 1, 2014

    Report

    Report Number
    3004209178-2014-12313
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Report Date
    June 6, 2014
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0J8G1, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ASKED FOR FIELD REPRESENTATIVE TO SPEAK WITH A PATIENT. THE PATIENT REPORTS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE EVENT OCCURRED THE DAY BEFORE REPORTED EVENT DATE. IT WAS NOTED THAT THE PATIENT WAS WORKING WITH REPRESENTATIVE. THE PATIENT HAD FOR 1.5 MONTHS AND STARTING YESTERDAY CONTINUOUS ACCIDENTS AND GOT IT UP TO 4.5 VOLTS AND THE PATIENT STATES SHE DOESN¿T KNOW WHAT TO DO. THE PATIENT STATES IT¿S LIKE WEARING A POOPY DIAPER. LOAD OF STOOL YESTERDAY. THE PATIENT STATES SHE DOESN¿T WANT TO INCREASE AS REPRESENTATIVE SAID SHE DOESN¿T ALWAYS NEED TO INCREASE. THE PATIENT WAS HOPING THE REPRESENTATIVE CAN CALL HER AS HER SYMPTOMS HAVE RETURNED AND SHE WAS VERY WORRIED. ADDITIONAL INFORMATION RECEIVED REPORTS THE EVENT CAUSE WAS UNKNOWN. THE PATIENT CALLED THE REPRESENTATIVE AND INTERSTIM WAS ADJUSTED FOUR DAYS BEFORE REPORTED EVENT DATE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT HAD NO APPOINTMENT AS OF YET. IT WAS NOTED THAT THE PATIENT RECEIVED PHONE ASSISTANCE FROM MANUFACTURER REPRESENTATIVE AND MAY SEEK HELP FROM HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THE REPRESENTATIVE MET THE PATIENT IN PERSON ON (B)(6) 2014. HE INDICATED THAT HE WANTED TO TROUBLESHOOT OVER THE PHONE, BUT THE PATIENT HAD A LOT OF ANXIETY, SO HE HAD TO MEET HER IN PERSON TO REPROGRAM. THE REPRESENTATIVE SAID THAT HE CHANGED PROGRAMMING SETTINGS AND DECREASED THE AMPLITUDE. HE SAID THAT AT THE BEGINNING OF THE APPOINTMENT THE PATIENT WAS FEELING THE STIMULATION IN THE BUTTOCK BUT AFTERWARD THEY FELT IT IN THE VAGINAL AND RECTAL AREA, WHICH WAS WHERE THEY WERE TARGETING. THE PATIENT MENTIONED THAT THE STIMULATION WAS PAINFUL PREVIOUSLY AS WELL BECAUSE THEY HAD TURNED IT UP TO TRY TO OBTAIN RELIEF, SO THE REPRESENTATIVE INDICATED THAT THEY LOWERED THE AMPLITUDE. THE REPRESENTATIVE SAID HE TOLD THE PATIENT TO CALL HIM OR THE PHYSICIAN IF THE SYMPTOMS RETURNED AND NEITHER OF THEM HAD HEARD FROM THE PATIENT. THE PATIENT HAD RECEIVED FIFTY PERCENT OR GREATER SYMPTOM REDUCTION SINCE IMPLANT AND THE REPRESENTATIVE WAS UNSURE WHAT HAPPENED TO CAUSE THE LOSS OF EFFICACY, BUT THAT THE REPROGRAMMING ON (B)(6) 2014 WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384948 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR