BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1945853 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-21505
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    September 30, 2010
    Report Date
    October 12, 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

    ATTEMPTS TO RECREATE THE NOISE WAS UNSUCCESSFUL. NO INTERVENTION WAS PERFORMED AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. AS OF TODAY THE LEAD REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD OVERSENSED NOISE RESULTING IN PACING INHIBITION. THE PATIENT WAS PACEMAKER DEPENDENT AND AS SUCH WAS ASYSTOLIC FOR MORE THAN TWO CONSECUTIVE SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 4518| 4524| H219| 4470| 0175