BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 340 VR-T

    MDR report key: 1140268 · Received August 29, 2008

    Report

    Report Number
    1028232-2008-01058
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    March 12, 2008
    Report Date
    July 28, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    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 ACCOMPANYING THIS PARTICULAR DEVICE. 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. THE COMPLAINT DESCRIPTION INDICATED THAT THE PROGRAMMING WAND WAS PLACED A SHORT DISTANCE TO THE DEVICE WHILE CHARGING. DUE TO THIS SHORT DISTANCE BETWEEN THE PROGRAMMING WAND AND THE ICD, A SATURATION OF THE TRANSFORMER MAY APPEAR DURING A CHARGING CYCLE, LEADING TO A TEMPORARY DROP OF THE SUPPLY VOLTAGE BELOW THE EOS LEVEL, RESULTING IN THE BATTERY STATUS EOS. FURTHERMORE, IT WAS REPORTED THAT THE EIGM FROM INDUCTION WAS NOT AVAILABLE. THIS INDICATES THAT A RESET APPEARED FOLLOWING THE REPORTED EXTERNAL DEFIBRILLATION. THE ICD IS, BY DESIGN, PROTECTED AGAINST DAMAGE FROM EXTERNAL DEFIBRILLATION SHOCKS. DUE TO THE VERY HIGH SHOCK ENERGIES, IT CAN NOT BE EXCLUDED, HOWEVER, THAT AN EXTERNAL DEFIBRILLATION CAUSES A DEVICE RESET, RESULTING IN THE OBSERVED "RESET ABORT" AND INCOMPLETE IEGM. IN SUMMARY, THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM. THE OBSERVED CLINICAL EVENT RESULTED FROM THE MAGNETIC FIELD OF THE PROGRAMMING WAND PLACED IN A SHORT DISTANCE AND SUBSEQUENTLY FROM A SPECIFIC HARDWARE PROTECTION FUNCTIONALITY IN THE CASE OF AN EXTERNAL DEFIBRILLATION.

    Description of Event or Problem · 1

    DURING THE IMPLANTATION PROCEDURE, THE DEVICE WENT INTO AN EOS STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 VR-T ICD LWS BIOTRONIK GMBH AND CO. 355271

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization