BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1853548 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14903
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THIS PATIENT IS DEVICE-DEPENDANT. THE PHYSICIAN HAD ELECTED TO CHANGE THE SENSITIVITY AND DO FURTHER DEFIBRILLATION THRESHOLD TESTING.

    Additional Manufacturer Narrative · 1

    INFORMATION SUGGESTS THESE PRODUCTS REMAIN IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ALSO NOTED, THESE STORED EPISODES WERE NOTED WHILE THE PATIENT WAS ON A TREADMILL. SOME NOISE WAS REPRODUCIBLE. SHOCK IMPEDANCE VALUES THAT WERE MEASURED DURING ISOMETRICS WERE STABLE AND WITHIN RANGE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED EXTERNAL NOISE ON THIS DEFIBRILLATION AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL LEAD. THIS NOISE RESULTED IN PACING INHIBITION. HOWEVER, THE SHOCK MORPHOLOGY SHOWS WHAT COULD BE AN INTRINSIC QRS COMING THROUGH. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 0158| 5076| E110| T165