BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXTRUS 4136

    MDR report key: 2980775 · Received February 19, 2013

    Report

    Report Number
    1028232-2013-00330
    Event Type
    Death
    Date Received
    February 19, 2013
    Date of Event
    August 2, 2012
    Report Date
    February 6, 2013
    Manufacturer
    BIOTRONIK SE & CO, KG
    Product Code
    NVZ
    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 RECEIVED INFORMATION THAT THIS PT PASSED AWAY SEVEN DAYS POST-IMPLANT. OUR COMPANY BECAME AWARE WHEN THE PT'S DAUGHTER CALLED MEDICAL RECORDS STATING THE PT DEATH WAS DUE TO A PUNCTURED LUNG THAT OCCURRED DURING THE IMPLANT PROCEDURE. IT IS NOT KNOWN IF THE PRODUCTS WERE REMOVED FROM THE PT POST-MORTEM. THE FIELD REP THAT WAS PRESENT AT THE PROCEDURE CONFIRMED HE WAS NOT AWARE OF THE REPORTED EVENTS, BUT WOULD FOLLOW UP WITH THE IMPLANTING PHYSICIAN FOR ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72868 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO, KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death