BEUDAMED
    FDA Adverse Event Death Summary report: N

    LYRA

    MDR report key: 475225 · Received August 4, 2003

    Report

    Report Number
    2184056-2003-00036
    Event Type
    Death
    Date Received
    August 4, 2003
    Date of Event
    June 1, 2003
    Report Date
    August 4, 2003
    Manufacturer
    ANGEION CORP.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS ICD WAS SCHEDULED FOR EXPLANTATION AS A RESULT OF THE ANGEION INITIATED "FIELD ACTION" FOR POSSIBLE PREMATURE BATTERY DEPLETION CONCERNING ALL ANGEION MANUFACTURED LYRA MODEL ICD'S. THE BATTERY VOLTAGE ON THIS DEVICE FELL WITHIN THE RANGE WHERE ANGEION RECOMMENDED EXPLANTATION. HOWEVER, IN 2003, ELA MEDICAL, INC. WAS NOTIFIED THAT THE PT PASSED AWAY SOMETIME IN 2003 BEFORE THIS DEVICE COULD BE EXPLANTED. THE CAUSE OF DEATH IS UNK AT THIS TIME. ELA IS IN THE PROCESS OF GATHERING FURTHER INFO FROM THE PHYSICIAN TO VERIFY IF THE PT'S DEATH IS DEVICE RELATED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYRA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ANGEION CORP. 2021 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R