BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2801247 · Received October 23, 2012

    Report

    Report Number
    3004209178-2012-09437
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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 LOT# V714946 SERIAL#, IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED, THE PATIENT HAD A HARD TIME REGULATING SINCE IMPLANT. THE PATIENT TURNED UP HER DEVICE ON (B)(6) 2012, AND IT SEEMED LIKE IT WAS WORKING OKAY FOR THREE DAYS BUT THEN IT SEEMED LIKE IT WENT "HAYWIRE." THE PATIENT DID NOT FEEL LIKE IT WAS WORKING SO SHE "UPPED IT A LITTLE BIT." THE PATIENT WAS STILL GETTING UP EVERY 1.5-2 HOURS TO GO TO THE BATHROOM. IT WAS NOTED, THE PATIENT WAS ABLE TO "SORT OF" HOLD IT BUT NOW SHE LEAKED BEFORE SHE COULD GET TO THE BATHROOM. THE PATIENT HAD A HARD TIME GETTING HER DEVICE TO INCREASE OR DECREASE AND WHEN SHE GOT IT TO INCREASE IT FELT LIKE IT WAS GOING INTO HER LEFT BUTT CHEEK. IT WAS NOTED SOMETIMES, THE PATIENT WAS ABLE TO GET STIMULATION IN HER BLADDER. IT WAS ALSO REPORTED, THE STIMULATION SENSATION DID NOT FEEL THE SAME AS WHEN SHE WAS IN THE HOSPITAL. IT WAS REPORTED, THE PATIENT WAS PROGRAMMED ON PROGRAM 1 AT 3 VOLTS, 2 AT 1.4 V, PROGRAM 3 AT 1.2 V, AND 4 AT 0 V. THE PATIENT HAD NOT CHANGED ANY OF HER PROGRAMS. IT WAS REPORTED, THE PATIENT WAS WORSE NOW THAN SHE WAS PRIOR TO IMPLANT. IT WAS NOTED, THE PATIENT WAS TAKING MEDICATIONS PRIOR TO IMPLANT. THE PATIENT SWITCHED TO PROGRAM 2 AT 3 V AND FELT STIMULATION IN THE HIGHER PART OF HER LEG INSTEAD OF HER BLADDER. IT WAS REPORTED, THE PATIENT FELT THE STIMULATION WAS "NOT STIMULATION THAT MUCH BUT WAS MORE OF A DULL HURT." THE PATIENT SWITCHED TO PROGRAM 3 WHICH FELT LIKE IT DID WHEN SHE WAS IN THE HOSPITAL AND PROGRAM 4 FELT LIKE A KNIFE. THE PATIENT HAD A FOLLOW-UP APPOINTMENT ON (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY A MONTH LATER REPORTED THE CAUSE OF THE EVENT WAS A URINARY TRACT INFECTION. THE PATIENT EXPERIENCED BURNING AND FREQUENCY. PATIENT OUTCOME WAS REPORTED AS NON-SERIOUS INJURY/ILLNESS. ADDITIONAL INFORMATION RECEIVED TWO DAYS LATER REPORTED, THE PATIENT WAS FEELING STIMULATION IN HER BOWELS MORE THAN HER BLADDER. THE PATIENT WAS GOING TO THE BATHROOM EVERY 1-1.5 HOURS LIKE SHE DID BEFORE IMPLANT. IT WAS REPORTED WHEN THE PATIENT HAD PROGRAM 3 AT 5 V IT "BURNED." A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention