BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 3231497 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01915
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 6, 2013
    Report Date
    July 2, 2013
    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. THE VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE CONDUCTOR COIL WHICH OCCURRED MOST LIKELY DURING SURGERY. IN THE COURSE OF THE FURTHER ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR LEAD EXPERIENCED A SYNCOPAL EPISODE WHILE WALKING UP A FLIGHT OF STAIRS. REVIEW OF STORED DEVICE MEMORY REVEALED AN EPISODE OF NOISE AND OVERSENSING OR A POTENTIAL EPISODE OF VENTRICULAR TACHYCARDIA. IT WAS UNABLE TO BE DETERMINED IF THE EPISODE WAS A TRUE VT, HOWEVER, THE PHYSICIAN FELT THAT IT WAS NOISE ON THE LEAD. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330687 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization