BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEXOS DR-T

    MDR report key: 729686 · Received June 14, 2006

    Report

    Report Number
    1028232-2006-00046
    Event Type
    Other
    Date Received
    June 14, 2006
    Date of Event
    March 29, 2006
    Report Date
    June 12, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    LWS
    PMA / PMN Number
    p000009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE STATUS WAS BOL. A NUMBER F 48 CHARGING CYCLES WAS DOCUMENTED. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI BRADYCARDIA PACING PULSES PROVED TO BE FLOWLESS AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DELIVERED DEFIBRILLATION SHOCKS AS SPECIFIED WITH A CHARGING TIME OF LESS THAN 10 SECONDS. THE DELIVERED SHOCK ENERGY WAS RECORDED AND INSPECTED. THE SPECIFIED ENERGY LEVEL WAS REACHED. IN SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. BY DESIGN, THE MAXIMUM DEFIBRILLATION SHOCK ENERGY AVAILABLE IS 30 JOULE. PMA NUMBER IS P000009.

    Description of Event or Problem · 1

    DEVICE RETURNED WITH OOS REPORT INDICATING THAT THE PT WAS UNABLE TO DEFIBRILLATE. DEVICE EXPERIENCE ON THE FORM INDICATES THAT THE ICD DID NOT DELIVER SHOCK/THERAPY, BUT THIS WAS MARKED BY MISTAKE. THE DEVICE DELIVERED SHOCK THERAPY, BUT DID NOT SUCCESSFULLY DEFIBRILLATE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEXOS DR-T ICD LWS BIOTRONIK GMBH AND CO 347 001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization