BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 3880302 · Received June 18, 2014

    Report

    Report Number
    1028232-2014-02012
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    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

    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. DURING THE MECHANICAL INSPECTION A STYLET COULD NOT BE PROPERLY INTRODUCED AND ADVANCED WITHIN THE LEAD'S LUMEN. FURTHER ANALYSIS REVEALED COAGULATED BLOOD IN THE LEAD. THESE BLOOD RESIDUALS WERE MOST LIKELY INTRODUCED INTO THE LEAD BY MEANS OF STYLETS USED DURING THE SURGERY. FURTHER INSPECTION SHOWED CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE OUTER COIL. THE SILICONE SEALING OF THE IS-1 CONNECTOR PIN WAS FOUND DAMAGED. THESE DAMAGES OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. THE VALUES OF THE PARAMETERS MEASURED DURING THE ELECTRICAL ANALYSIS OF THE LEAD PROVED TO BE WITHIN THE TECHNICAL SPECIFICATIONS. IN SUMMARY, COAGULATED BLOOD WAS FOUND IN THE LEAD. THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH RIGHT VENTRICULAR LEAD EXHIBITED UNDERSENSING. THIS RV LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357842 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization