BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 VR-T (XL)

    MDR report key: 3083053 · Received April 29, 2013

    Report

    Report Number
    1028232-2013-01130
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    December 16, 2012
    Report Date
    April 16, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD FIRST UNDERWENT A VISUAL EXAMINATION. A SPARKOVER TRACE WAS FOUND ON THE ICD HOUSING, WHICH INDICATES A SPARKOVER BETWEEN THE HV CONDUCTOR OF THE LEAD AND THE ICD HOUSING. IN ADDITION, TRACES OF ABRASION WERE DETECTED ON THE HOUSING. THE ICD THEN UNDERWENT AN ELECTRICAL EXAMINATION. THE CLINICAL OBSERVATION WAS CONFIRMED, THE ICD COULD NOT BE INTERROGATED. THE MEMORY CONTENT OF THE DEVICE COULD THEREFORE NO LONGER BE READ. NEXT, THE DEVICE WAS OPENED. A DESTROYED FINAL SHOCK STAGE OF THE ELECTRONIC MODULE WAS IDENTIFIED. THIS DAMAGE TO THE FINAL SHOCK STAGE INDICATES A SHOCK DELIVERY INTO AN EXTERNAL LOW-OHMIC SHOCK PATH. THE DAMAGE TO THE MODULE LEAD, IN TURN, TO A PERMANENTLY INCREASED CURRENT UPTAKE AND CONSEQUENTLY TO A DISCHARGE OF THE BATTERY AND THE RESULTING LACK OF INTERROGATION CAPABILITY OF THE ICD. THERE WERE NO SPARKOVER TRACES OR SHORT-CIRCUITS WITHIN EITHER THE ICD OR THE CONNECTION SYSTEM, WHICH COULD BE RELATED TO THE CLINICAL OBSERVATION. THE LOW-OHMIC SHOCK PATH CLEARLY RESULTED FROM AN EXTERNAL SHORT-CIRCUIT. THE MANUFACTURING PROCESS FOR THIS DEVICE 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.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 13 MONTHS, AN INSULATION DEFECT WITH SPARKOVER AT SHOCK DELIVERY WAS REPORTED. NO DETERIORATION IN THE PATIENT'S STATE OF HEALTH WAS REPORTED. A NEW ICD AND LEAD WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183597 LUMAX 340 VR-T (XL) ICD LWS BIOTRONIK SE & CO. KG 357889

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization