BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 3232139 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01924
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 22, 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 INSPECTION DEMONSTRATED SEVERE DEFORMATIONS OF THE INNER COIL CLOSE TO THE IS-1 CONNECTOR PIN. THE INSULATION WAS FOUND DAMAGED IN THIS AREA. THE SUBSEQUENT ANALYSIS INDICATED THAT THESE DAMAGES WERE CAUSED BY OVERROTATION. COAGULATED BLOOD WAS IDENTIFIED IN THE LUMEN OF THE LEAD CAUSING THE INABILITY TO ADVANCE THE STYLET PROPERLY. THESE BLOOD RESIDUALS WERE MOST LIKELY INTRODUCED INTO THE LUMEN OF THE LEAD BY MEANS OF STYLETS USED DURING THE SURGERY. IN SUMMARY, THE INNER COIL OF THIS LEAD WAS FOUND TO BE DEFORMED AND COAGULATED BLOOD WAS IDENTIFIED IN THE LUMEN OF THE LEAD. THESE DAMAGES AFFECTED THE ACTIVE FIXATION MECHANISM. NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM WAS PRESENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXPLANTED DUE TO A PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330755 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization