BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 3874210 · Received June 16, 2014

    Report

    Report Number
    1028232-2014-01976
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    April 26, 2014
    Report Date
    June 5, 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 WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION WHICH OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. BLOOD PENETRATED THE LEAD IN THIS AREA. DURING FURTHER ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN PARTICULAR, THE VALUES OF THE PARAMETERS MEASURED DURING THE ELECTRICAL ANALYSIS OF THE LEAD PROVED TO BE WITHIN THE TECHNICAL SPECIFICATIONS. IN SUMMARY, CUTTINGS IN THE INSULATION WERE FOUND. THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE AND LOSS OF CAPTURE. NO GREATER THAN TWO SECOND'S ASYSTOLE WAS NOTED. ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT AN ACUTE INFLAMMATORY RESPONSE IN THE LEAD TIP OR TISSUE INTERFACE AREA WAS SUSPECTED. THE LEAD HAD HIGH PACING THRESHOLD MEASUREMENT AND NORMAL RANGE IMPEDANCE WITH PACING SYSTEM ANALYZER. NORMAL CONNECTIONS WERE ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED. THE DEVICE WAS REPROGRAMMED AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352305 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization