BEUDAMED
    FDA Adverse Event Other Summary report: N

    TACHOS ATX

    MDR report key: 526332 · Received February 11, 2004

    Report

    Report Number
    1028232-2003-00325
    Event Type
    Other
    Date Received
    February 11, 2004
    Date of Event
    July 28, 2003
    Report Date
    January 29, 2004
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REP ATTEMPTED TO INTERROGATE THIS DEVICE AND REC'D AN ERROR MESSAGE STATING ERROR STATUS 0011 0008. FOLLOWING INTERROGATION, REP DISCOVERED THAT TACHY THERAPY HAD BEEN DISABLED. WHEN REP ATTEMPTED TO ENABLE V THERAPY, REP REC'D AN ERROR MESSAGE STATING THAT THERAPY COULD NOT BE ENABLED DUE TO LOW BATTERY STATUS OR SYSTEM ERROR; MEASURED BATTERY STATUS AND VOLTAGE = BOL IN 2003. CALL REC'D FROM REP REGARDING ERROR 0011 0008 AND INABILITY TO INTERROGATE DEVICE. SYSTEM RESET ATTEMPTED. NO RESULTS, DEVICE REMAINS WITH ERROR CODE AND UNRESPONSIVE TO INTERROGATEION. IN 2003 TSV SUGGESTED THAT REP ATTEMPTED TO RESET THE DEVICE. DEVICE RESET WAS SUCCESSFUL; DEVICE REMAINS IMPLANTED AND FUNCTIONING NORMALLY. THE RECOMMENDATION TO EXPLANT THE DEVICE WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TACHOS ATX ICD MRM BIOTRONIK GMBH & CO. 122 499 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization