BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 VR-T (XL)

    MDR report key: 3021826 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00832
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    December 1, 2012
    Report Date
    March 15, 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 RETURNED LEAD AND THE INCLUDED ICD DATA WERE THOROUGHLY ANALYZED. THE ICD WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS AND THE INCLUDED ICD DATA. THE MANUFACTURING PROCESS FOR THIS DEVICE 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. THE RETURNED DATA CONFIRMED THE CLINICAL OBSERVATION. INTERFERENCE COULD BE SEEN IN THE AVAILABLE IEGMS. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS FOR EITHER THE ICD OR THE LEAD.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF 38 MONTHS, OVERSENSING AND INAPPROPRIATE SHOCKS WERE REPORTED. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED. THE LEAD WAS EXPLANTED. THERE IS NO INDICATION THAT THIS DEVICE WAS EXPLANTED AND NO IMPLANT OR EXPLANT DATE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123683 LUMAX 340 VR-T (XL) ICD LWS BIOTRONIK SE & CO. KG 357889

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization