BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 VR-T

    MDR report key: 1366173 · Received January 26, 2009

    Report

    Report Number
    1028232-2009-00014
    Event Type
    Malfunction
    Date Received
    January 26, 2009
    Date of Event
    December 11, 2009
    Report Date
    January 13, 2009
    Manufacturer
    BIOTRONIK, GMH AND CO
    Product Code
    MRM
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS AS WELL AS ON THE RETURNED PROGRAMMER PRINTOUTS AND THE RETURNED ICD MEMORY DUMP. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. DURING THE INSPECTION OF THE PROGRAMMER PRINTOUTS, THE DESCRIBED ABORTED 38 J SHOCK WAS CONFIRMED. FURTHER INSPECTION OF THE AVAILABLE DATA YIELDED NO DEFINITE EXPLANTATION. FOR FURTHER ANALYSIS, AN ICD MEMORY DUMP WAS PROVIDED. THE ANALYSIS OF THE MEMORY CONTENT SHOWED THAT AN INTERNAL RESET HAD BEEN TRIGGERED DURING A CHARGING CYCLE. THIS REPRESENTS A SINGULAR EVENT NOT OBSERVED BEFORE. AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. ALTHOUGH THE SUBSEQUENT CHARGING CYCLE PROVED TO BE AS SPECIFIED, RE-OCCURRENCE CAN NOT BE EXCLUDED TOTALLY AS THIS POINT. DESPITE THE SINGULAR NATURE OF THIS OBSERVATION, TO EXCLUDE ANY POTENTIAL HARM FOR THE PT, WE RECOMMEND TO REPLACE THE DEVICE AS A PRECAUTIONARY STEP AND TO RETURN IT FOR ANALYSIS TO BIOTRONIK. OF COURSE, INDIVIDUAL CIRCUMSTANCES AND MEDICAL JUDGMENT DETERMINE DECISIONS ABOUT PT CARE.

    Description of Event or Problem · 1

    DURING IMPLANTATION, THE FIRST 10J INDUCTION SHOCK DID NOT CONVERT. THE DEVICE RE-DETECTED CORRECTLY, BUT THE 38J SHOCK WAS NOT DELIVERED. THE FIBRILLATION WAS THEREFORE, TERMINATED WITH AN EXTERNAL DEFIBRILLATOR. DURING THE NEXT INDUCTION ATTEMPT, THE DEVICE SUCCESSFULLY TERMINATED THE FIBRILATION WITH 15J. THE DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 VR-T ICD MRM BIOTRONIK, GMH AND CO 355271

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention