BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTINEL

    MDR report key: 613107 · Received July 19, 2004

    Report

    Report Number
    2184056-2004-00026
    Event Type
    Injury
    Date Received
    July 19, 2004
    Date of Event
    December 10, 2003
    Report Date
    July 19, 2004
    Manufacturer
    ANGEION CORPORATION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 62+ MONTHS OF IMPLANTATION, THIS ICD WAS EXPLANTED AND RETURNED BECAUSE IT WAS REPORTED THAT THE DEVICE HAD REACHED END OF LIFE (EOL). HOWEVER, THE ANALYSIS REVEALED THAT EXCESSIVE CHARGE TIME SET THE BATTERY INDICATOR TO EOL. NOTE: DURING AN INTERNAL REVIEW PROCESS, ELA MEDICAL INC. DISCOVERED THAT THIS CASE WAS INADERTENTLY NOT SUBMITTED IN MAY 2004. THEREFORE, THE MDR IS BEING SUBMITTING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ANGEION CORPORATION 2010 9630301B

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R