BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINOX SD 65/16

    MDR report key: 1671365 · Received April 26, 2010

    Report

    Report Number
    1028232-2010-00851
    Event Type
    Death
    Date Received
    April 26, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 26, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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

    PRIOR TO IMPLANTING THIS LEAD, A BUNDLE BRANCH BLOCK WAS NOTED ON A SURFACE ECG. DURING IMPLANTATION OF THE LEAD, WHILE THE LEAD WAS CROSSING THE ATRIO-VENTRICULAR NODE, ASYSTOLE WAS NOTED. EXTERNAL PACING THROUGH THIS LEAD WAS CONDUCTED, AND CAPTURE WAS NOTED. THE PT'S RHYTHM THEN DEGENERATED INTO VENTRICULAR FIBRILLATION AND THE PT EXPIRED. THIS LEAD WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death