BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3145710 · Received June 4, 2013

    Report

    Report Number
    3004209178-2013-08618
    Event Type
    Injury
    Date Received
    June 4, 2013
    Report Date
    June 18, 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
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V872660, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WOULD BE MEETING WITH THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2013. IT WAS NOTED THE PATIENT WAS DOING MUCH BETTER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A PLAN TO ¿REINSERT BATTERY PLACEMENT¿ IN THE NEXT TWO TO THREE MONTHS AND PATIENT OUTCOME WAS NOTED AS SERIOUS ILLNESS/INJURY ¿ ONGOING. IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY ON (B)(6) 2013 AND THE CAUSE OF DEATH WAS CARDIAC ARREST. THERE WAS NO INDICATION THAT THE DEATH WAS RELATED TO THE DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT WITH LOSS OF BLADDER CONTROL. IT WAS NOTED THAT THE PATIENT WASN'T GETTING THERAPEUTIC EFFECT STATING "IN FACT IT GOT REALLY REALLY BAD". THERE WAS STIMULATION SENSATION. THE ISSUE OCCURRED FOLLOWING A FALL. THE PATIENT FELL IN THE BATHTUB IN ABOUT (B)(6) 2012. THE PATIENT WENT TO HER MANAGING HEALTHCARE PROVIDER'S (HCP) OFFICE ON TUESDAY ((B)(6) 2013) AND SOME REPROGRAMMING WAS PERFORMED. THE PATIENT WAS TOLD THAT SHE NEEDED TO FIND "BASELINE" AGAIN AND TO TRY EACH OF HER 4 PROGRAMS FOR A WEEK AND TO JOURNAL THERAPEUTIC EFFECTS. THE PATIENT DID NOT KNOW HOW LONG SHE WAS SUPPOSED TO JOURNAL FOR AND HAD HER NEXT HCP APPOINTMENT SCHEDULED FOR (B)(6) 2013. THE PATIENT WAS INSTRUCTED TO TURN STIM OFF YESTERDAY ((B)(6) 2013) AND KEEP IT OFF UNTIL TOMORROW ((B)(6) 2013). IT WAS NOTED THAT HER HCP DIDN'T THINK ANYTHING WAS WRONG WITH HER DEVICE. THE PATIENT HAD AN OVERSTIMULATION SENSATION WITH ACUTE PAIN. WHEN THE PATIENT LEFT THE HCP'S OFFICE ON TUESDAY HER STIM WAS ON, AT PROGRAM 4 AT 6.5. WHEN THE PATIENT WENT TO GET OUT OF HER CAR, "IT HURT SO BAD" AND SHE EXPERIENCED PAINFUL STIMULATION WHEN SHE WAS MOVING AROUND STATING "IT HURT SO BAD TO WALK YOU KNOW". THE LOCATION OF THE PATIENT'S SYMPTOMS WAS THE PERINEUM. THE PAIN WAS "STRAIGHT ACROSS THE CRACK" IN BUTTOCKS AND DOWN. IT WAS LIKE THE AREA WHERE YOU GET "SADDLE SORE". MOVEMENT CAUSED STIMULATION CHANGES. WHEN THE PATIENT TURNED STIM OFF YESTERDAY ((B)(6) 2013) THE PAIN WENT AWAY. THE PATIENT WAS UNSURE ABOUT TURNING STIM BACK ON AGAIN TOMORROW ((B)(6) 2013) BECAUSE STIM WAS PAINFUL FOR HER WHEN SHE MOVED AROUND. THE PATIENT DECLINED DECREASING STIM. IT WAS ALSO NOTED THAT THE PATIENT "HAVEN'T DONE WHAT AT TIMES I WAS SUPPOSED TO BE TOLD TO DO". IT WAS NOTED THAT THE PATIENT WENT THROUGH A "REALLY BAD THING OF DEPRESSION THERE FOR A WHILE" AND SHE SAW HER PRIMARY HCP WHO CHANGED HER DEPRESSION MEDS. IT WAS ALSO REPORTED THAT THE PATIENT "HAD BEEN UP FOR DAYS" WITHOUT SLEEPING, AND WOULD GET TIRED AND CRANKY AND ALSO WAS ON A C-PAP MACHINE . THE PATIENT WAS NOT SURE WHEN THIS TOOK PLACE, BUT THOUGHT IT WAS SHORTLY AFTER HAVING HER INTERSTIM IMPLANTED. THE PATIENT NOTED: "WHEN YOU GET IN THAT STATE YOU DON'T CARE ABOUT NOTHING'". THE PATIENT NOTED THAT SHE WAS ON A "BREATHING MACHINE FOR 48 HOURS" AND THEN PATIENT STARTED TO DISCUSS ADVERSE EVENTS WITH REGARD TO HER DEFIBRILLATOR SHOCKING HER. THE PATIENT NOTED THAT IT TOOK PLACE A LONG TIME AGO AND THAT SHE WAS FINE "AND THE DOCTORS OFFICE HAS ALL THAT". THE FOLLOWING SERVICE OR EDUCATION ISSUE(S) WERE NOTED: PATIENT LACKED BASIC UNDERSTANDING OF: THE THERAPY. IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT HAD AN AP AND LATERAL X-RAY AND NO LEAD DISPLACEMENT WAS NOTED. THEY WERE WORKING WITH THE PATIENT ON RE-PROGRAMMING OPTIONS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED ON (B)(4) 2013 THAT THE MANUFACTURER'S REPRESENTATIVE WAS GOING TO TRY TO MEET WITH THE PATIENT THE FOLLOWING WEEK, IF POSSIBLE, TO SEE IF THEY COULD CHANGE PROGRAMS. IF THIS IS NOT SUCCESSFUL, THEY PLANNED TO DISCUSS OPTIONS WITH PHYSICIAN ON HOW TO PROCEED. IT WAS LATER REPORTED ON (B)(4) 2013 THAT THE REPRESENTATIVE WAS STILL TRYING TO SCHEDULE A TIME TO MEET WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246636 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention