BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3416496 · Received October 17, 2013

    Report

    Report Number
    3007566237-2013-03392
    Event Type
    Injury
    Date Received
    October 17, 2013
    Report Date
    September 30, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT# V072754, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT'S BATTERY WENT OUT IN (B)(6) 2013. THE (B)(6) WOULDN'T WORK ON THE PATIENT DUE TO RISK FACTORS AS THEY WORKED ON HIS COLON. A DOCTOR TOLD THE PATIENT TO SPEAK TO AN ANESTHESIOLOGIST TO SEE IF HE COULD HAVE A SURGERY BEFORE HE COULD GET A NEW IMPLANT. THE PATIENT WAS WONDERING HOW TO KNOW, HOW THEY WOULD KNOW IF THE LEAD WAS STILL GOOD. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CAUSE OF THE EVENT WAS NORMAL BATTERY DEPLETION. HOSPITALIZATION WAS NOT REQUIRED. IT WAS NOTED THAT THERE WAS NO "EVENT". NORMAL BATTERY DEPLETION OCCURRED AND THE PATIENT WAS NOT HEALTHY ENOUGH TO UNDERGO ANESTHESIA FOR REPLACEMENT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 NOTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. PATIENT NOTES: I AM NOT SURE OF THE OPERATION, I HAVE A PACEMAKER AND I HAVE DIABETES 2. WHAT I WOULD LIKE TO HAVE DONE IS TO HAVE X-RAYS OF THE INTERSTIM INSIDE ME AND I WOULD LIKE TO TALK TO ANESTHESIA TO SEE IF I CAN GO THROUGH WITH THE OPERATION. GENERATOR BATTERY MUST NOT WORK. I AM NOT SURE WHAT IS WRONG. IN 2012 THE BATTERY OR GENERATOR STOPPED WORKING. PATIENT WENT TO A THIRD DOCTOR WHO AT THAT TIME FELT THAT THE PATIENT COULD LIVE WITH IT IN THEM. BUT IT WASN'T WORKING AND HE TOOK AN X-RAY BUT DID NOT DO ANYTHING, I WENT BACK TO THE DOCTOR IN (B)(6) AND ASKED HIM WHAT TO DO BUT HE DID NOT SUGGEST ANY X-RAYS OR TESTS TO SEE IF I COULD WITHSTAND THE OPERATION. I DID NOT KNOW WHAT TO DO. I CALLED THE (B)(6) TO SEE ABOUT PAYING FOR THE OPERATION, SO THEY SENT ME BACK TO THE DOCTOR WHO SAID HE WOULD DO THE OPERATION. BUT HE DID NOT TAKE ANY TESTS ON ME. SO THEY DID A CATHETERIZATION ON ME TO SEE IF I WAS BLEEDING INSIDE MY URINARY TRACT WHICH I WAS NOW. FROM CATHETERIZATION THAT NIGHT AND FOR 3 WEEKS I GOT UP ONCE ONLY OR DID NOT WET MY SHORTS OR DIAPER. FOR 3 WEEKS IT WAS GREAT. BUT THEN IT STARTED AGAIN TO GET UP 3 OR 4 TIMES TO URINATE. BY MORNING I HAD 600 CC IN THE BOTTLE AND AT TIMES WHEN SITTING AND WATCHING TV I WOULD GET UP AND HAD TO URINATE BEFORE I WOULD WET MY SHORTS. BUT NOW AT NIGHT I GET UP 3 TIMES AND URINATE 700 CC OR MORE BEFORE I WET MY SHORTS. THE PATIENT NOTED THEY WERE ON BLOOD THINNER, WARFARIN, HIGH BLOOD PRESSURE, INSULIN, DIABETES AND OTHER MEDICATIONS. THE (B)(6) WAS WORKING TO SEE IF THEY WERE "ELIGIBLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532397 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention