BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 3160173 · Received June 10, 2013

    Report

    Report Number
    1028232-2013-01632
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    May 31, 2013
    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 WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, AN ELECTRICAL AND A MECHANICAL INSPECTION. DURING THE VISUAL INSPECTION A BEND IN THE LEAD'S DISTAL PART WAS NOTED. BENDING THE DISTAL PART REQUIRES THE PRESENCE OF MECHANICAL STRESS. TRACTION FORCES DURING SURGERY SHOULD BE TAKEN INTO CONSIDERATION. THE CUTTINGS OF THE INSULATION OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. DURING FURTHER ANALYSIS, NO OTHER DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN SUMMARY, A BEND IN THE LEAD'S DISTAL PART WAS NOTED. THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEXTRUS ATRIAL LEAD WAS EXHIBITING INTERMITTENT CAPTURE DUE TO DISLODGEMENT. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED. NO ADVERSE EVENTS HAVE BEEN REPORTED. THE EVENT AND EXPLANT DATES WERE LEFT OUT OF THIS REPORT SINCE THEY DID NOT MAKE SENSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260323 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization