BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2586375 · Received May 21, 2012

    Report

    Report Number
    1028232-2012-01229
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Date of Event
    March 16, 2012
    Report Date
    May 8, 2012
    Manufacturer
    BIOTRONIK, INC.
    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 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 LEAD WAS EXPLANTED DUE TO HIGH ATRIAL THRESHOLD MEASUREMENTS. NO ADVERSE PT EFFECTS WERE REPORTED. AT THIS TIME THE LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THERE IS NO ADD¿L INFO AVAILABLE. IF FURTHER INFO BECOMES AVAILABLE. THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK, INC. 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization