BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 740 VR-T PROMRI

    MDR report key: 3021834 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00795
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    November 26, 2012
    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 REVIEW OF THE MANUFACTURING PROCESS FOR THIS ICD 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.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF 8 MONTHS, OVERSENSING WAS REPORTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD ENGAGED IN WEIGHT TRAINING DURING REHABILITATION. NO DETERIORATION IN THE PATIENT'S STATE OF HEALTH WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124013 LUMAX 740 VR-T PROMRI ICD LWS BIOTRONIK SE & CO. KG 381459

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization