BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 300 VR-T

    MDR report key: 4210997 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003757
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    August 28, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH RETURNED ICDS WERE VISUALLY INSPECTED AFTER RECEIPT, NO ANOMALIES WERE FOUND. DURING THE INITIAL INTERROGATION, THE CLINICAL OBSERVATION WAS CONFIRMED, BOTH DEVICES COULD NOT BE INTERROGATED. THE MEMORY CONTENT OF BOTH DEVICES AN THEREFORE NO LONGER BE READ. NEXT, BOTH ICDS WERE OPENED, AND THE RESPECTIVE INTERNAL STRUCTURE WAS EXAMINED. IN THE PROCESS, A DAMAGED FINAL SHOCK STAGE OF THE ELECTRONIC MODULE WAS IDENTIFIED IN BOTH THE ONE AND THE OTHER ICD. THIS DAMAGE OF THE FINAL SHOCK STAGE INDICATES A SHOCK DELIVERY INTO AN EXTERNAL LOW-OHM SHOCK PATH. THIS IS CONSISTENT WITH THE REPORTED CLINICAL IMPEDANCE MEASUREMENT OF <25 OHM. IN BOTH ICDS, THE DAMAGE TO THE ELECTRONIC MODULE THEN LED TO A PERMANENTLY INCREASED CURRENT UPTAKE AND, SUBSEQUENTLY, TO BATTERY DISCHARGE AND THE RESULTING LACK OF INTERROGATIBILITY. THERE WERE NO SPARK OVER TRACES OR SHORT-CIRCUITS IN EITHER THE ICD OR THE CONNECTION SYSTEMS, WHICH COULD BE RELATED TO THE CLINICAL OBSERVATION. THE LOW-OHMIC SHOCK PATH RESULTED CLEARLY FROM AN EXTERNAL SHORT-CIRCUIT IN BOTH CASES. POSSIBLE CLINICAL COMPLICATIONS THAT COULD LEAD TO AN EXTERNAL SHORT-CIRCUIT ARE, AMONG OTHERS, THE TWIDDLER SYNDROME, THE SUBCLAVIAN CRUSH SYNDROME, OR OTHER DAMAGE TO THE LEAD INSULATION THAT LEADS TO CONTACT BETWEEN THE HIGH-VOLTAGE CONDUCTORS. THE MANUFACTURING PROCESS OF BOTH DEVICES WAS REVIEWED. THE PRODUCTION DOCUMENTS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS HAD BEEN CARRIED OUT CORRECTLY. SUMMARY FOR BOTH ICDS, THE ANALYSIS SHOWED DAMAGE TO THE FINAL SHOCK STAGE DUE TO A SHOCK DELIVERY INTO AN EXTERNAL LOW-OHMIC SHOCK PATH, CONSISTENT WITH THE REPORTED CLINICAL IMPEDANCE MEASUREMENT OF <25 OHM. THE DAMAGE TO THE FINAL SHOCK STAGE IN BOTH CASES RESULTED IN A COMPLETE DISCHARGE OF THE BATTERY, WHICH LED TO THE CLINICAL OBSERVATION. THIS IS NOT A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    OUS - IT WAS REPORTED THAT THIS ICD SHOWED A BATTERY CAPACITY OF 43% IN JUNE AND COULD NO LONGER BE INTERROGATED ON (B)(6) 2014. FURTHERMORE, IT WAS REPORTED THAT DURING IMPLANTATION OF THE NEW ICD, A SHORT-CIRCUIT OCCURRED AFTER THE DEFIBRILLATION TEST. THE LEAD, WHICH HAD BEEN ASSESSED AS INTACT BEFORE, SHOWED A SHOCK IMPEDANCE OF <25 OHM WHEN TESTED. THE LEAD AND THE ICD WERE EXCHANGED. BOTH ICDS WERE RETURNED TO BIOTRONIK FOR ANALYSIS. WE WERE NOT INFORMED OF THE WHEREABOUTS OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691608 LUMAX 300 VR-T ICD LWS BIOTRONIK SE & CO. KG 355270

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization