BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXTRUS 4137

    MDR report key: 3010558 · Received March 19, 2013

    Report

    Report Number
    1028232-2013-00701
    Event Type
    Death
    Date Received
    March 19, 2013
    Date of Event
    November 27, 2012
    Report Date
    March 5, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF 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 FROM A COMPETITOR EXPLANT FORM IN LATE (B)(6) 2013 THAT THIS PATIENT DIED IN (B)(6) 2012 AND THE DEVICE WAS EXPLANTED IN (B)(6) 2012. THE CAUSE OF DEATH WAS LISTED AS GROUP B STREPTOCOCCUS BACTERIA, SEPSIS AND AORTIC STENOSIS. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE SPOKE DIRECTLY WITH THE PHYSICIAN. ACCORDING TO THE PHYSICIAN, THE ROOT CAUSE OF THE INFECTION WAS UNKNOWN. THE PHYSICIAN FELT THAT THE IMPLANT PROCEDURE DID NOT CAUSE OR CONTRIBUTE TO THE INFECTION OR PATIENT DEATH. THE LOCAL REPRESENTATIVE WAS UNAWARE THAT THIS PATIENT HAD DEVELOPED AN INFECTION AND DIED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114156 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Death