BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3978440 · Received August 4, 2014

    Report

    Report Number
    3004209178-2014-13933
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    July 14, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 093-28, LOT# VA01R0Z, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE REASON FOR THE CALL WAS A REPROGRAMMING APPT. THE CALLER WAS MEETING WITH PATIENT TODAY BECAUSE OF BATTERY CHECK AND SYSTEM CHECK. THE CALLER DID A FOLLOW UP CALL TO CHECK ON THE PATIENT IN THE LAST 2 WEEKS AND THE PATIENT NOTED THAT THE SYSTEM HADN'T BEEN WORKING. THE CALLER HADN'T HEARD FROM THE PATIENT IN OVER A YEAR AND HAD NO IDEA HOW LONG IT HADN'T BEEN WORKING. THE CALLER ATTEMPTED TO INTERROGATE AND THE PATIENT PROGRAMMER THE PATIENT BROUGHT WITH TODAY SHOWED THAT THE PATIENT PROGRAMMER WASN'T BONDED TO INS. IT WAS NOTED THAT THE PATIENT MOST LIKELY HAS ANOTHER ICON FROM HER PREVIOUS IMPLANT. THE PATIENT TOLD THE CALLER THAT SHE HAD BEEN CHANGING PROGRAMS IN THE PAST WITH NO SUCCESS IN THERAPY BUT REVIEWED THAT THE PATIENT PROGRAMMER SHE BROUGHT IN TODAY WILL ONLY INC/DEC/ON/OFF. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453000 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1