BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 540 VR-T DX

    MDR report key: 3853804 · Received June 6, 2014

    Report

    Report Number
    1028232-2014-01864
    Event Type
    Death
    Date Received
    June 6, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 27, 2014
    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 DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS AND ON THE TRANSMITTED FOLLOW-UP DATA. THE MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE CARRIED OUT CORRECTLY. DURING THE INSPECTION OF THE AVAILABLE IEGMS FROM (B)(6) 2014, THE CLINICAL OBSERVATION COULD BE CONFIRMED; WEAKLY DEVELOPED INTRINSIC SIGNALS WERE DETECTED IN THE RIGHT-VENTRICULAR CHANNEL, WHILE NO SIGNALS WERE SENSED AT THE SAME TIME IN THE FAR-FIELD CHANNEL. BASED ON THE AVAILABLE DATA, THERE WAS NO INDICATION OF A MALFUNCTION OF THE ICD. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS, AND THE PRODUCTION HISTORY DID NOT SHOW ANY ANOMALIES.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 45 MONTHS, IT WAS REPORTED THAT THE PATIENT WAS FOUND DEAD IN THE HOSPITAL ROOM ON (B)(6) 2014. THE ICD WAS NOT RETURNED TO BIOTRONIK AND IS BURIED TOGETHER WITH THE PATIENT. AT THE CURRENT TIME, THERE ARE NO INDICATIONS OF A CONNECTION BETWEEN THE ICD AND THE DEATH. THE REPORT IS THEREFORE MADE PURELY OUT OF CAUTION, ON TIME, AND WITHOUT INDICATIONS OF MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332007 LUMAX 540 VR-T DX ICD LWS BIOTRONIK SE & CO. KG 368852

    Patients

    Seq Age Sex Outcome Treatment
    1 Death