BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXTRUS 4136

    MDR report key: 1695368 · Received May 17, 2010

    Report

    Report Number
    1028232-2010-01065
    Event Type
    Death
    Date Received
    May 17, 2010
    Date of Event
    March 3, 2010
    Report Date
    April 22, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS PT PRESENTED TO THE HOSPITAL WITH CHEST PAIN AND PALPITATIONS. THE PT EXPIRED DUE TO PROBABLE SEPSIS, LEFT LOWER LOBE PNEUMONIA, LEFT PLEURAL EFFUSION, HYPERTENSION, STABLE CORONARY ARTERY DISEASE AND DIABETES MELLITUS. A BOSTON SCIENTIFIC CRM SALES REPRESENTATIVE WAS UNABLE TO CONFIRM THE CAUSE OF SEPSIS. IT IS UNK IF THIS LEAD WAS EXPLANTED OR BURIED WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death