BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053610 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05269
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    November 1, 2012
    Report Date
    March 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE WITH OVERSENSING AND PACING INHIBITION WERE NOTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM. THE PATIENT WAS PACEMAKER DEPENDENT, AND ASYSTOLE OVER TWO SECONDS WAS NOTED, BUT NO PT ISSUES WERE REPORTED. THE PATIENT WAS MONITORED IN THE HOSPITAL UNTIL SURGICAL INTERVENTION WAS PERFORMED. THE CRT-D WAS SUCCESSFULLY EXPLANTED AND REPLACED, AND THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED. THE HIGH VOLTAGE PORTION OF THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156624 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| L| R 4518| 0158| H175