BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEXOS DR-T

    MDR report key: 1463992 · Received September 2, 2009

    Report

    Report Number
    1028232-2009-01101
    Event Type
    Injury
    Date Received
    September 2, 2009
    Date of Event
    August 4, 2009
    Report Date
    August 4, 2009
    Manufacturer
    BIOTRONIK SE & CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REP. CALLED TO REPORT THIS PT WAS CALLED INTO THE DOCTOR'S OFFICE AFTER HOME MONITORING INDICATED THE DEVICE HAD REACHED ERI. UPON INTERROGATION, THE DEVICE BATTERY VOLTAGE WAS 5.85 V WITH ERI STATUS. SHE REPEATED THE TEST TWO MORE TIMES, AND MEASURED A BATTERY VOLTAGE OF 5.88 V AND 5.85 V, STILL WITH ERI STATUS. THERE WAS NO CLEAR REASON THAT ERI OCCURRED WELL ABOVE THE ERI VOLTAGE. THE DEVICE HAD NOT HAD ANY CHARGES EXCEPT FOR THE INDUCTION SHOCK AND AUTOMATIC CAPACITOR REFORMS. THE PACING OUTPUTS WERE SET TO 2.8 V AT 0.4 MSEC. THE PT WAS QUESTIONED, AND DID NOT RECALL HAVING ANY MEDICAL PROCEDURES OR BEING EXPOSED TO UNUSUAL SOURCES OF EMI. WE ATTEMPTED A CU RESET IN CASE THE ERI WAS FLAGGED IN ERROR. HOWEVER, AFTER A SUCCESSFUL CU RESET AND FIRMWARE UPDATE, THE DEVICE STILL INDICATED ERI STATUS. EXPLANT WAS RECOMMENDED AND THE DEVICE WILL BE RETURNED FOR ANALYSIS FOLLOWING EXPLANT. ON AUG 25, 2009, WE WERE INFORMED THAT THIS DEVICE WAS EXPLANTED IN 2009 AND DISCARDED BY THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEXOS DR-T ICD LWS BIOTRONIK SE & CO. 347001

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization