BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 3021914 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00827
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 15, 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

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING 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 MANUFACTURING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED NOISE WHICH CORRESPONDS WITH NOISE ON THE SHOCK CHANNEL. THE DEVICE WAS PROGRAMMED TO VENTRICULAR PACING AND SENSING, INHIBIT PACING, AND RATE RESPONSE (VVIR) LAST MONTH DUE TO ATRIAL NOISE. THE DEVICE WAS PROGRAMMED BACK TO DUAL CHAMBER PACING AND SENSING, TRIGGER AND INHIBIT PACING, AND RATE RESPONSE (DDDR). BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONTACTED REGARDING THIS ISSUE AND DISCUSSED MUSCLE ARTIFACT ON SHOCK CHANNEL CAN BE NORMAL. THERE WAS NO NOISE NOTED ON THE PACE/SENSE CHANNEL. ALL OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE PHYSICIAN IS CONSIDERING AN ATRIAL LEAD REVISION PROCEDURE AS THE PATIENT IS CURRENTLY HOSPITALIZED FOR ATRIAL FIBRILLATION WITH SHOCK DUE TO CONDUCTION TO THE VENTRICULAR FIBRILLATION ZONE. TECHNICAL SERVICES SUGGESTED INSPECTING THE SHOCKING CONNECTOR IF AN ATRIAL LEAD REVISION IS DONE. ALSO, CHECK THAT THE CONNECTIONS ARE ACCURATE AS SEEING ATRIAL ACTIVITY ON THE SHOCK CHANNEL COULD BE THAT THE HIGH VOLTAGE CONNECTORS ARE REVERSED IN THE HEADER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123586 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization