BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 VR-T

    MDR report key: 3241120 · Received July 22, 2013

    Report

    Report Number
    1028232-2013-01880
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 2, 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

    THE ICD FIRST UNDERWENT A STATUS INTERROGATION. THE DEVICE STATUS WAS ERI, 390 CHARGE PROCESSES HAD BEEN DOCUMENTED. THE MEMORY CONTENT OF THE ICD WAS CHECKED; INTERFERENCE IN THE VENTRICULAR CHANNEL WAS VISIBLE ON THE AVAILABLE IEGMS. THE SIGNAL SENSING OF THE ICD WAS THEN CHECKED AND PROVED TO BE FREE OF NOISE. THE ICD SENSED SUPPLIED SIGNALS FREE OF INTERFERENCE. A CHECK OF THE IMPEDANCE MEASUREMENT FUNCTIONS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO THE CLINICAL OBSERVATION. THE ICD FUNCTIONED PROPERLY. THE ICD'S CAPABILITY TO PROVIDE THERAPY WAS TESTED. THE ANTIBRADYCARDIC OUTPUT SIGNAL WAS NORMAL AND MATCHED THE PROGRAMMED VALUES. A FIBRILLATION SIGNAL WAS SUPPLIED, AND THE DEVICE REACTED ACCORDING TO SPECIFICATION WITH A DEFIBRILLATION SHOCK. THE SPECIFIED ENERGY LEVEL WAS REACHED. THE CHARGE TIME WAS UNREMARKABLE. IN SUMMARY, THE ICD PROVED TO BE IN ORDER DURING THE ANALYSIS. THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE SPECIFICATION THAT COULD BE RELATED TO THE CLINICAL OBSERVATION. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS FOR EITHER THE LEAD OR THE ICD.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 17 MONTHS, OVERSENSING WAS REPORTED. IT WAS ALSO REPORTED THAT A DAMAGED INSULATION WAS NOTED DURING THE REVISION ABOUT 5 CM BELOW THE FORK. THE LEAD WAS CUT OFF IN THAT AREA AND CAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341401 LUMAX 340 VR-T ICD LWS BIOTRONIK SE & CO. KG 355271

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization