BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 VR-T

    MDR report key: 3232149 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01932
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 4, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    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 INTERROGATION REVEALED THE BATTERY STATUS EOS. A NUMBER OF 256 CHARGING CYCLES WAS DOCUMENTED. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THE ANALYSIS OF THE AVAILABLE IEGMS, ALL DATING FROM (B)(4) 2013, REVEALED THE PRESENCE OF NOISE IN THE RIGHT VENTRICULAR AND FAR-FIELD CHANNELS. THE DETECTION OF NOISE IN THE VENTRICULAR CHANNEL LED TO AN AMOUNT OF MORE THAN 120 CHARGING CYCLES OF WHICH MORE THAN 50 RESULTED IN SHOCK DELIVERIES. HENCE A SENSING TEST WAS PERFORMED AND THE DEVICE SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE, PROVING THE SENSING FUNCTION OF THE ICD TO BE FAULTLESS. THE ANALYSIS OF THE SHOCK HOLTER SHOWED THAT THIS LARGE AMOUNT OF CHARGING CYCLES WAS PERFORMED BY THE DEVICE WITHIN ONE HOUR ON (B)(4) 2013. THE EOS STATUS OF THE DEVICE RESULTED FROM THAT SUCCESSIVE CHARGING. NEXT, THE DEVICE WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE EOS STATUS WAS REMOVED WITH A TECHNICAL PROGRAMMER AND SUBSEQUENT INTERROGATION SHOWED THE BATTERY STATUS ERI. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTIBRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DELIVERED A DEFIBRILLATION SHOCK AS SPECIFIED, DOCUMENTING A CORRECT SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED. THE ICD WAS IMPLANTED FOR 30 MONTHS; 256 CHARGING CYCLES WERE DOCUMENTED IN THE ICD'S MEMORY. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. THE BATTERY CONDITION WAS FOUND TO BE ANTICIPATED.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN ESTIMATED IMPLANT DURATION OF 2 YEARS OVERSENSING WITH 57 INAPPROPRIATE SHOCKS WAS REPORTED. THE ICD WAS EXPLANTED DUE BATTERY DEPLETION AND RECEIVED FOR ANALYSIS. THE LEAD COULD NOT BE EXPLANTED. NO IMPLANT OR EXPLANT DATE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332244 LUMAX 540 VR-T ICD LWS BIOTRONIK SE & CO. KG 360348

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization