BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3974111 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13865
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 7, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA051YE, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE THAT THE PATIENT STATES HER MOST RECENT IMPLANT WORKED FOR 3 DAYS THEN STOPPED WORKING. THE PATIENT STATES SHE HAD ALSO BEEN TAKING 2 DIFFERENT ORAL MEDICATIONS IN ADDITION TO STIMULATOR DEVICE AND NOTHING HELPED HER SYMPTOMS. THE PATIENT STATES SHE HAS BEEN REPROGRAMMED SEVERAL TIMES AND IT WAS STILL NOT HELPING HER SYMPTOMS. THE PATIENT INQUIRED ABOUT HAVING THE THERAPY REMOVED. THE PATIENT STATES SHE DOES NOT HAVE A HEALTHCARE PROVIDER. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT APPOINTMENT WAS SCHEDULED FOR (B)(6) 2014.

    Description of Event or Problem · 1

    EIGHT MONTHS LATER, IT WAS REPORTED THAT THERE WAS A GRADUAL LOSS OF THERAPEUTIC EFFECT. NO ACTIONS WERE TAKEN, BUT THE PATIENT WAS GOING TO CALL THEIR GYNECOLOGIST AND SCHEDULE AN APPOINTMENT. THE PATIENT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450738 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR