BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYRA

    MDR report key: 5350425 · Received September 10, 2004

    Report

    Report Number
    2184056-2004-00033
    Event Type
    Injury
    Date Received
    September 10, 2004
    Report Date
    September 10, 2004
    Manufacturer
    ANGEION CORP.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    ON SEPTEMBER 10, 2004. (B)(4). THE RECALL # IS: Z-1152/1154-02. NOTIFICATION AND PATIENT MONITORING ALSO APPLY. A RESPONSE FROM THE MANUFACTURER IS PENDING.

    Description of Event or Problem · 1

    THIS ICD WILL BE EXPLANTED AS A RESULT OF THE ANGEION INITIATED "FIELD ACTION" FOR POSSIBLE PREMATURE BATTERY DEPLETION CONCERNING ALL ANGEION LYRA MODEL ICD'S. THE BATTERY VOLTAGE ON THIS DEVICE FELL WITHIN THE RANGE WHERE ANGEION RECOMMENDED EXPLANATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYRA LWS ANGEION CORP. 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R