BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 2072629 · Received April 22, 2011

    Report

    Report Number
    1028232-2011-00926
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    February 2, 2011
    Report Date
    April 13, 2011
    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 MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 MFG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO ENDOCARDITIS. IT WAS NOTED THAT THE PT HAD A HEART VALVE REPLACED A FEW WEEKS BEFORE. THE FIELD REPRESENTATIVE INDICATED THEY WERE UNSURE IF THE DEVICE WAS RELATED TO THE INFECTION. THE PT CURRENTLY HAS A LIFEVEST AND MAY HAVE A NEW DEVICE IMPLANTED ONCE THE INFECTION HAS CLEARED. AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFO IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization