BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 3853803 · Received June 6, 2014

    Report

    Report Number
    1028232-2014-01880
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    January 2, 2014
    Report Date
    May 23, 2014
    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 A CALL FROM THE PATIENT'S SPOUSE STATING THE PATIENT PASSED AWAY APPROXIMATELY ONE MONTH AFTER HAVING THEIR SYSTEM EXPLANTED DUE TO AN ICD LEAD INFECTION. THE PATIENT'S SPOUSE WAS UNWILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE INFECTION AND CAUSE OF DEATH. THE PATIENT'S CLINIC WAS CONTACTED FOR ADDITIONAL INFORMATION AND CONFIRMED THE PATIENT HAD VEGETATIVE GROWTH ON THEIR LEADS. THE LEADS WERE EXPLANTED USING LASER EXTRACTION AND THE PULSE GENERATOR WAS REMOVED. THE CLINIC WAS NOT AWARE OF THE PATIENT'S DEATH, BUT DID NOTE THAT THE PATIENT DID NOT RECEIVE A REPLACEMENT SYSTEM. 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
    332498 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H