BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 4240531 · Received November 10, 2014

    Report

    Report Number
    1028232-2014-004007
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 27, 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 UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL AND ELECTRICAL INSPECTION. THE VISUAL INSPECTION DEMONSTRATED A DAMAGED FIXATION. THE HELIX WAS FOUND CUT OFF AND WAS NOT RETURNED FOR ANALYSIS. FURTHER INSPECTION REVEALED SEVERAL EXPLANTATION DAMAGES SUCH AS CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE INNER AND OUTER CONDUCTOR COIL. THE DISTAL PART OF THE LEAD WAS PARTLY PULLED OUT OF THE RING ELECTRODE. AS THE ROOT CAUSE OF THE OBSERVED DAMAGES, TENSILE FORCES APPLIED DURING THE EXPLANTATION PROCEDURE SHOULD BE TAKEN INTO CONSIDERATION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PHYSICIAN ATTEMPTED PLACING THIS LEAD IN THE ATRIUM SEVERAL TIMES HOWEVER THIS LEAD KEPT ON DISLODGING. THE LEAD HELIX WAS OPERATING NORMALLY WITHOUT ANY TISSUE LODGED IN THE HELIX MECHANISM BUT IT WAS OBSERVED THAT THE PATIENT'S ATRIUM WAS EXTREMELY LARGE WITH LOTS OF SCAR TISSUE. THE PHYSICIAN STATED THERE WAS NOTHING WRONG WITH THE LEAD BUT DECIDED TO USE A COMPETITOR LEAD INSTEAD. THIS LEAD WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723621 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization