BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 740 VR-T

    MDR report key: 4210992 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003831
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    March 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE IMPLANTATION THE PATIENT HAD PAIN. THE STERILIZATION PROCESS WAS INVESTIGATED. THE VALIDATED PROCESS ASSURES THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., ARE WITHIN ITS SPECIFIED RANGES FOR EACH DISTRIBUTED DEVICE. ADDITIONAL AN ANALYSIS OF VALIDATED MICROBIOLOGICAL INDICATORS IS PERFORMED AFTER EVERY STERILIZATION PROCEDURE AS EVIDENCE OF SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. REVIEW OF THE BIOTRONIK COMPLAINT DATABASE DID NOT REVEAL ANY CHANGES REGARDING THE TREND FOR THIS TYPE OF INCIDENT. IN SUMMARY, THE INFECTION WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THIS DEVICE AND THE ASSOCIATED LEAD WERE EXPLANTED AT THE PATIENT'S REQUEST DUE TO PAIN. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692035 LUMAX 740 VR-T ICD LWS BIOTRONIK SE & CO. KG 365609

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization