BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMAX 340 VR-T

    MDR report key: 1894179 · Received November 4, 2010

    Report

    Report Number
    1028232-2010-02281
    Event Type
    Other
    Date Received
    November 4, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    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

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    PATIENT HAD SURGERY AND THEY USED ELECTROSURGICAL CAUTERY. UPON INTERROGATION AFTER THE SURGERY, THE DEVICE WAS READING AS EOS. ADDITIONAL INFORMATION OBTAINED FOR THIS EVENT SUGGESTS THE PATIENT HAD BEEN UNDERGOING A MEDICAL STERNOTOMY AND A LUNG BIOPSY. THE REPRESENTATIVE STATED THAT THIS DEVICE HAD BEEN RESET FOLLOWING THE SURGERY AND WAS FUNCTIONING APPROPRIATELY. THE PATIENT IS DOING WELL AND THE DEVICE IS REMAINS ACTIVELY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 VR-T ICD LWS BIOTRONIK SE & CO. KG 355271

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O