BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 3160153 · Received June 10, 2013

    Report

    Report Number
    1028232-2013-01642
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 31, 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

    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. THE LEAD WAS VISUAL ANALYSED AND 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. FURTHER VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE OUTER COIL WHICH OCCURRED MOST LIKELY DURING SURGERY. DURING FURTHER ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD WAS DISLODGED. THIS RA LEAD WAS EXPLANTED, REPLACED SUCCESSFULLY AND WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260771 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization