BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 2941692 · Received December 21, 2012

    Report

    Report Number
    1028232-2012-03330
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, A MECHANICAL AND AN ELECTRICAL ANALYSIS. DURING THIS ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN PARTICULAR, THE VALUES MEASURED DURING THE ELECTRICAL AND MECHANICAL ANALYSIS PROVED TO BE WITHIN SPECIFICATION. THE CUTTINGS OF THE INSULATION OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD DISPLAYED INAPPROPRIATE CAPTURE AND SENSING. THE LEAD WAS EXPLANTED AND REPLACED. THE LEAD HAS BEEN RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PT EFFECTS REPORTED. THE DATE OF EXPLANT WAS NOT PROVIDED.

    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