BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEXOS VR-T

    MDR report key: 1051874 · Received May 21, 2008

    Report

    Report Number
    1028232-2008-00523
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    December 7, 2007
    Report Date
    April 23, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE ICD DID NOT SHOW ANY INDICATIONS OF A DEVICE MALFUNCTION. THE CONSIDERABLE AMOUNT OF 618 CHARGE PROCESSES WAS THE RESULT OF THE DETECTION OF INTERFERENCE SIGNALS, WHICH HAD PROBABLY BEEN CAUSED BY A DEFECT LEAD INSULATION. AFTER SUCH A HIGH AMOUNT OF CHARGE PROCESSES, THE BATTERY STATUS EOS IS TO BE EXPECTED.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 6 MONTHS, PREMATURE BATTERY DEPLETION AND OVERSENSING WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEXOS VR-T ICD LWS BIOTRONIK GMBH AND CO. 346999

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization