BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4105466 · Received September 22, 2014

    Report

    Report Number
    3004209178-2014-17437
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V581929, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S FRIEND OR FAMILY MEMBER WAS NOT BEING ABLE TO ADJUST STIMULATION AND THE PATIENT PROGRAMMER DISPLAY SHOWED A ¿CALL YOUR DOCTOR¿ ICON AND HAD A POWER ON RESET (POR) CONDITION. THE PATIENT HAD A SHOCK TREATMENT TO PUT THEIR HEART BACK INTO RHYTHM AND THIS MORNING THEY SAW THE DOCTOR ICON ALONG WITH A ¿POV¿ MESSAGE ON THE PROGRAMMER. IT WAS CONFIRMED SEVERAL TIMES AND THEY INDICATED THEY SAW A POV MESSAGE AND NOT A POR MESSAGE. THE FRIEND OR FAMILY MEMBER WOULD GO TO SEE THE PATIENT LATER AND RECHECK THE PATIENT PROGRAMMER. THE PATIENT HAD THE SHOCK TREATMENT ON (B)(6) 2014 AND THE DEVICE WAS TURNED OFF AND THE PATIENT DECIDED TO LEAVE THE THERAPY OFF UNTIL THEY SAW THEIR CARDIOLOGIST. THE PATIENT HAD THEIR FIRST APPOINTMENT WITH THE CARDIOLOGIST ON (B)(6) 2014 AND THEY CONFIRMED THAT THE PATIENT¿S HEART RHYTHM CONTINUED TO BE REGULAR. THE PATIENT ATTEMPTED TO TURN THERAPY BACK ON 6 DAYS AGO AND SAW THE DOCTOR ICON. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588339 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR