BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 4240527 · Received November 10, 2014

    Report

    Report Number
    1028232-2014-004010
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 29, 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

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS FOUND DISSECTED. ALL FRAGMENTS WERE RECEIVED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED IN THE COURSE OF THE SURGERY. THE RETURNED LEAD FRAGMENTS WERE ANALYSED. THE VISUAL INSPECTION REVEALED CUTTINGS IN THE INSULATION WHICH OCCURRED MOST LIKELY DURING THE EXPLANT PROCEDURE. DURING THE ELECTRICAL ANALYSIS, THE DC RESISTANCES OF THE RECEIVED CONDUCTOR FRAGMENTS WERE MEASURED. NO PECULIARITIES WERE FOUND. DUE TO THE FRAGMENTATION OF THE LEAD, A THROUGHOUT ANALYSIS OF THE FIXATION MECHANISM WAS NOT FEASIBLE. HOWEVER THE FIXATION HELIX WAS INSPECTED AND COULD BE FULLY EXTENDED AND RETRACTED. FURTHERMORE, THE LENGTH OF THE FIXATION HELIX WAS IN ACCORDANCE WITH THE TECHNICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY IRREGULARITY THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED CLINICAL EVENT. THE ANALYSIS OF THE AVAILABLE LEAD FRAGMENTS DID NOT REVEAL ANY INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DAY POST IMPLANT, NO MEASUREMENTS WERE ABLE TO BE OBTAINED ON THIS RIGHT ATRIAL (RA) LEAD. IT WAS DETERMINED THAT THE LEAD WAS DISLODGED. SUBSEQUENTLY A LEAD REPLACEMENT PROCEDURE WAS DONE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724193 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization