BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 540 DR-T

    MDR report key: 3021788 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00778
    Event Type
    Death
    Date Received
    March 26, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE ICD WAS VISUALLY INSPECTED. THE VISUAL INSPECTION REVEALED SPOTS OF MOLTEN TITANIUM ON THE ICD HOUSING. THIS INDICATES AN ARC OVER FROM A HIGH VOLTAGE LEAD CONDUCTOR DURING A SHOCK DELIVERY, REPRESENTING AN EXTERNAL SHORT CIRCUIT. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS, THE DEVICE WAS NOT INTERROGATABLE. NEXT, THE ICD WAS OPENED AND THE INNER ASSEMBLY WAS INSPECTED. DURING THE INSPECTION OF THE ELECTRICAL MODULE, THE ANALYSIS REVEALED THAT THE OUTPUT STAGES OF THE HIGH VOLTAGE CIRCUIT HAD BEEN DAMAGED. THIS DAMAGE INDICATES A SHOCK DELIVERY INTO AN EXTERNAL SHORT CIRCUIT. DUE TO THE DAMAGE OF THE ELECTRICAL MODULE, THE DEVICE COULD NOT BE INTERROGATED PROPERLY. THIS IS CONSISTENT WITH THE OBSERVED SPOTS OF MOLTEN TITANIUM ON THE ICD HOUSING. 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 OBSERVED DAMAGE SYMPTOMS. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE FLAWLESS. IN SUMMARY, THE ICD WAS DAMAGED DUE TO A SHOCK DELIVERY INTO AN EXTERNAL SHORT CIRCUIT. A SHOCK DELIVERY INTO AN EXTERNAL SHORT CIRCUIT REQUIRES A DAMAGED INSULATION OF THE HIGH VOLTAGE LEAD (THE LEAD WAS AN OEM). THE MANUFACTURING RECORDS DOCUMENT A FLAWLESS DEVICE PRODUCTION. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO EMERGENCY CARE. HE HAD BEEN EXTERNALLY DEFIBRILLATED ABOUT 14 TIMES BY THE AMBULANCE OFFICERS BEFORE. THE DEVICE COULD NOT BE INTERROGATED. ON (B)(6) WE WERE INFORMED THAT THE PATIENT DIED SEVERAL DAYS AFTER THE EVENT. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124310 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 Death