BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 3012994 · Received February 26, 2013

    Report

    Report Number
    1028232-2013-00418
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BIOTRONIK, INC.
    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 PATIENT PRESENTED IN CLINIC FOR HIS STAPLE REMOVAL. INTERROGATION REVEALED THIS DEXTRUS ATRIAL LEAD WAS DISLODGED AND HANGING IN THE VENTRICLE. THEREFORE, A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPOSITIONED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADD¿ INFO IS RECEIVED,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83138 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK, INC. 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization