BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3866944 · Received June 11, 2014

    Report

    Report Number
    3004209178-2014-11430
    Event Type
    Injury
    Date Received
    June 11, 2014
    Report Date
    May 22, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V855336, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANT WAS NOT WORKING. THEY STARTED TO HAVE ISSUES A MONTH AGO. HOWEVER, YESTERDAY, THE PATIENT "THREW MY BACK OUT." THE PATIENT NOTED A SHOCKING OR JOLTING SENSATION. THE PATIENT ALSO NOTED A LOSS OF THERAPEUTIC EFFECT WITH LOSS OF BLADDER CONTROL. REGARDING WHEN DID THE EVENT OR SYMPTOMS OCCUR, IT WAS NOTED: FOLLOWING A POSITION CHANGE. YESTERDAY, AS THE PATIENT WAS STANDING UP, THEY "THREW MY BACK OUT." THE STIM WAS AT 4.0, BUT THEY DIDN'T REALLY FEEL THE STIM. THEN LAST NIGHT, THE PATIENT STARTED TO EXPERIENCE SHOCKING "FROM THE DEVICE" AND TURNED THE INS OFF. THIS STOPPED THE SHOCKING. HOWEVER, THE PATIENT WAS UP 6 TIMES DURING THE NIGHT. THE BATHROOM WAS 15 FT FROM THE BED, AND THE PATIENT COULD NOT MAKE IT AND WET SEVERAL PAIRS OF PJ'S. HAVING THE INS OFF STOPPED THE SHOCKING, BUT THE PATIENT STILL HAD GENERAL LOW BACK PAIN AND COULD HARDLY MOVE. IT WAS NOTED THAT THERAPY WAS NOT WORKING AS EXPECTED. THE PATIENT MENTIONED THEY HAVE "A-FIB WITHOUT INVOLVEMENT OF THE VALVES." ABOUT A MONTH AGO THE PATIENT WAS IN THE HOSPITAL FOR 3 DAYS DUE TO GREATLY FLUCTUATING HEART RATES - 180 DROPPING AS LOW AS 60. THE PATIENT WAS ON COUMADIN. A FIELD STAFF REQUEST WAS MADE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT THREW THEIR BACK OUT AND IT WAS NOTED AS A MUSCLE INJURY. THE PATIENT EXPERIENCED LOWER BACK MUSCULAR PAIN. THE INJURY RESULTED WHEN STANDING FROM A SEATED POSITION. THE PATIENT REPORTEDLY FELT ELECTRICAL JOLTING INSTEAD OF VIBRATION FOR 1 MONTH SINCE HURTING BACK. THE PATIENT WAS SEEN ON (B)(6) 2014. THE IMPEDANCES WERE WITHIN NORMAL RANGE AND THE BATTERY LIFE WAS NOTED AS 7-15 MONTHS. THE PATIENT WAS REPROGRAMMED WITH PROPER VAGINAL SENSATION AND NO ELECTRICAL JOLTING PAIN. THE PATIENT WAS CURRENTLY SET AT C+, 3- AT 0.8 VOLTS. THE EVENT DID NOT REQUIRE PATIENT HOSPITALIZATION. THE OUTCOME WAS NOTED AS A NON-SERIOUS INJURY/ILLNESS. THE PATIENT HAD A BATTERY REVISION TENTATIVELY SET FOR THE FALL OF 2014 IF THE PATIENT WAS SUCCESSFUL ON CURRENT SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345559 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention