BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 VR-T DX

    MDR report key: 3021831 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00797
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 12, 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 WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS AND THE RETURNED DEVICE DATA. THE MANUFACTURING PROCESS FOR THIS ICD 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. 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 16 MONTHS, IT WAS REPORTED THAT THE SHOCK IMPEDANCE DETERMINED VIA HOME MONITORING WAS OUTSIDE OF THE MEASUREMENT RANGE. THE MEASUREMENTS DURING THE FOLLOW-UP DID NOT SHOW ANY ANOMALIES. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED. THE LEAD AND THE ICD WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124012 LUMAX 540 VR-T DX ICD LWS BIOTRONIK SE & CO. KG 368852

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization