BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2914120 · Received December 7, 2012

    Report

    Report Number
    1028232-2012-03126
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    May 17, 2012
    Report Date
    November 23, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    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 FOUND DISSECTED. ONLY THE PROXIMAL FRAGMENT WAS RECEIVED. THE FRAGMENTATION OF THE LEAD MOST LIKELY ORIGINATED FROM THE EXPLANTATION PROCEDURE. THE RETURNED DEVICE WAS VISUALLY AND ELECTRICALLY ANALYZED. THE INSPECTION OF THE INSULATION CONFIRMED THAT THE LEAD WAS, APART FROM THE PRESENT CUTTINGS, FREE OF INSULATION BREACHES. IN ADDITION, THE DC RESISTANCES OF THE CONDUCTOR FRAGMENTS WERE INVESTIGATED AND PROVED TO BE FLAWLESS. NO PECULIARITIES WERE FOUND. THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. IN SUMMARY, NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM WAS NOTED DURING ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT AT IMPLANT OF THIS RIGHT VENTRICULAR LEAD, HIGH THRESHOLD MEASUREMENTS WERE NOTED. ADDITIONALLY, IMPEDANCE MEASUREMENTS WERE WITHIN RANGE BUT ELEVATED AND SLIGHTLY HIGHER UTILIZING THE PACING SYSTEM ANALYZER. FOLLOWING IMPLANT, THRESHOLD MEASUREMENTS HAD INCREASED, IMPEDANCE COULD NOT BE MEASURED, NO CAPTURE WAS OBSERVED AND NO SENSING MEASUREMENTS COULD BE OBTAINED IN UNIPOLAR CONFIGURATION. THE PT HAS A PRESSURE DRESSING AND THERE IS SOME FLUID IN THE POCKET. NO ADVERSE PT EFFECTS WERE REPORTED. NO EXPLANT DATE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization