BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 340 VR-T

    MDR report key: 1032068 · Received April 21, 2008

    Report

    Report Number
    1028232-2008-00380
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 20, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR ICD AND ALSO THE PRODUCTION LOT HAVE BEEN RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST OF THIS ICD AND THE PRODUCTION LOT. THE BIOTRONIK STERILIZATION PROTOCOL CONFIRMED THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., WERE IN THEIR SPECIFIED RANGES. ALSO, THE INVESTIGATION OF THE MICROBIOLOGICAL INDICATORS SHOWED THE SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. IN SUMMARY, THE INFECTION WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    PER REP, THIS LEFT-SIDED SYSTEM WAS EXPLANTED DUE TO INFECTION AND EROSION. THE PT HAS VERY THIN SKIN. THIS IS THE SECOND INFECTION AND THE FIRST EROSION FOR THIS PT. THE SYSTEM WILL NOT BE RETURNED TO BINC. ALSO REMOVED. LKNOX TD 65/18, MDR 1028232-2008-00381.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 VR-T 60412328 LWS BIOTRONIK GMBH AND CO. 355271

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization