BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 640 DR-T PROMRI

    MDR report key: 3160140 · Received June 10, 2013

    Report

    Report Number
    1028232-2013-01630
    Event Type
    Death
    Date Received
    June 10, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 31, 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 A SPOT OF MOLTEN TITANIUM ON THE ICD HOUSING. FURTHERMORE, ARC-OVER MARKS WERE ALSO OBSERVED ON THE SHOCK COIL OF THE HIGH VOLTAGE LEAD. THIS INDICATES AN ARC OVER FROM THE HIGH VOLTAGE LEAD SHOCK COIL TO THE ICD HOUSING DURING A SHOCK DELIVERY, REPRESENTING AN EXTERNAL SHORT CIRCUIT. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THEREBY THE CLINICAL OBSERVATION WAS CONFIRMED, 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. 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. BASED ON THESE FINDINGS, IT IS REASONABLE TO ASSUME THAT THE ICD DAMAGE OCCURRED AFTER THE EXPLANTATION OF THE SYSTEM WHILE THE SHOCK PATH WAS TEMPORARILY SHORTED. CONCLUSIVELY, IT IS THEREFORE ASSUMED THAT THE ICD WAS CAPABLE TO DETECT AND DELIVER ANTITACHYCARDIA THERAPY WHILE IMPLANTED AND IN SERVICE. THIS IS CONSISTENT WITH THE REPORT THAT THE ANTI-TACHYCARDIA THERAPY FUNCTIONS WERE NOT DEACTIVATED BEFORE EXPLANTATION AND THAT THE HOME MONITORING DATA DOCUMENTS A FLAWLESS DEVICE BEHAVIOR WHILE THE ICD WAS IMPLANTED AND IN SERVICE. THE PERFORMANCE OF THE LEADS WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION OF THE DEFIBRILLATION LEAD REVEALED THE SPOT OF MOLTEN TITANIUM ON THE SHOCK COIL. BESIDE THIS FINDING NO DEVIATIONS WERE NOTED DURING ANALYSIS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEADS PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. IN SUMMARY, THE ICD WAS DAMAGED DUE TO A SHOCK DELIVERY INTO AN EXTERNAL SHORT CIRCUIT. IT WAS REPORTED THAT THE THERAPY FUNCTIONS OF THE ICD WERE NOT DEACTIVATED DURING THE EXPLANTATION. THE COILED UP AND TEMPORARILY SHORTED LEADS CAUSED NOISE, LEADING TO DEFIBRILLATION SHOCKS AND THEREFORE TO THE OBSERVED DAMAGE OF THE DEVICE. THE LEADS PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. THERE WAS NEITHER FOR THE ICD NOR FOR THE LEADS ANY INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - EIGHT DAYS POST IMPLANTATION IT WAS REPORTED THAT THE PATIENT EXPIRED. THE ICD COULD NOT BE INTERROGATED. THERE WAS NO CAUSE OF DEATH PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260258 LUMAX 640 DR-T PROMRI ICD MRM BIOTRONIK SE & CO. KG 381470

    Patients

    Seq Age Sex Outcome Treatment
    1 Death