BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3802497 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08795
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 21, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA01HA5, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE REPRESENTATIVE ADJUSTED THE DEVICE ABOUT TWO WEEKS PRIOR AND STIMULATION WAS ¿TOO INTENSE.¿ IT WAS STATED THAT IT WAS ¿TOO STRONG¿ RIGHT AWAY AFTER PROGRAMMING, BUT THE REPRESENTATIVE WANTED THE PATIENT TO TRY IT FOR TWO WEEKS BECAUSE THEY WERE GETTING INTO PAIN WITH A DIFFERENT PROGRAM. IT WAS STATED THE REPRESENTATIVE PUT IT ON THE ¿STANDARD.¿ THE DEVICE WAS GIVING THE PATIENT PAIN. STIMULATION WAS SET AT 0.55V ON PROGRAM 4. IT WAS NOTED THE PATIENT¿S SETTINGS HAD BEEN AT 1.45V FOR YEARS AND THE REPRESENTATIVE REPROGRAMMED THE ¿WHOLE THING.¿ IT WAS STATED THE PROGRAM WENT FROM ¿45 TO 50¿ AND THE OTHER PROGRAM WOULD INCREASE ¿ONE AT A TIME.¿ THE CURRENT PROGRAM REPORTEDLY FELT LIKE IT WAS ¿RIGHT ON THE NERVE¿ AND EVEN WHEN DECREASING, IT DID NOT TAKE THE PAIN AWAY. IT WAS LATER REPORTED THE PATIENT STILL HAD TWO DEVICES IMPLANTED AND ONE WAS ACTIVE. IT WAS STATED THE PATIENT¿S COMPLAINT REGARDING STRENGTH OF STIMULATION HAD BEEN ADDRESSED AND THE PATIENT WAS RECEIVING APPROPRIATE THERAPY. IT WAS NOTED THE PATIENT WAS TENTATIVELY SCHEDULED FOR A REPLACEMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281809 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention