BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC II HF CRT-D

    MDR report key: 2242610 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06648
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    June 15, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS CONFIRMED THAT DEVICE HAD REACHED END OF LIFE. LV PACING CAPTURE THRESHOLDS WERE FOUND TO BE HIGHER EARLIER IN THE IMPLANT THAN THEY WERE AT END OF IMPLANT. IT IS SUSPECTED THAT HIGHER PACING SETTINGS WERE RESPONSIBLE FOR THE REPORTED BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED EOL (END OF LIFE) PREMATURELY. IT WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC II HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-355 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention