BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 VR-T

    MDR report key: 3083113 · Received April 29, 2013

    Report

    Report Number
    1028232-2013-01252
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    December 5, 2012
    Report Date
    April 17, 2013
    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 ICD WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS AND THE SUPPLIED 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. THE ANALYSIS OF THE SUPPLIED DATA WAS ABLE TO CONFIRM THE CLINICAL OBSERVATION AND IS CONSISTENT WITH THE RESULTS OF THE LEAD ANALYSIS. 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 - OVERSENSING WAS REPORTED. NO IMPLANT DATE WAS PROVIDED. ONLY THE ASSOCIATED LEAD WAS EXPLANTED. ALL AVAILABLE INFORMATION SUGGESTS THIS ICD REMAINS ACTIVELY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183274 LUMAX 540 VR-T ICD LWS BIOTRONIK SE & CO. KG 360348

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization