BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC II PLUS HF CRT-D

    MDR report key: 3090025 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01293
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    October 24, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE DEVICE WAS RETURNED FOR PREMATURE BATTERY DEPLETION. REAL TIME TRENDING DATA REVEALED THAT THE DEVICE WAS PROGRAMMED OUT OF SHIP SETTINGS WHILE STILL IN THE ORIGINAL PACKAGING. BATTERY TRENDING DATA THE DAY OF THE IMPLANT IS N/A DUE TO HV CHARGING ACTIVITY PRIOR TO IMPLANT. THE FIRST TRENDING DATA FOR BATTERY VOLTAGE 4 DAYS AFTER IMPLANT IS 2.68V. THIS SUGGESTS THAT MULTIPLE HV CHARGES MAY HAVE OCCURRED PRIOR TO IMPLANT. BATTERY VOLTAGE TRENDING DATA FOLLOWING THE 2.68V MEASUREMENT APPEARED NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO PREMATURE ERI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192410 EPIC II PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-357 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention