BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 2914118 · Received December 7, 2012

    Report

    Report Number
    1028232-2012-03123
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    October 22, 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 SUBJECTED TO AN EXTENSIVE ANALYSIS, INCLUDING A VISUAL AND ELECTRICAL INSPECTION. THE ANALYSIS OF THE LEAD DEMONSTRATED A DAMAGED INSULATION AT THE DISTAL PART OF THE LEAD. IN THAT SECTION, THE LEAD BODY WAS FOUND RUBBED THROUGH. THIS DAMAGE CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IT IS ASSUMED THAT THE LEAD HAS BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS A RESULT OF AN INTERACTION BETWEEN THE LEAD BODY AND THE TRICUSPID VALVE. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. THE VISUAL INSPECTION SHOWED A BENT OUTER CONDUCTOR COIL IN THE SECTION BEHIND THE IS-1 CONNECTOR PIN AS WELL AS A KINK. FURTHERMORE THE LEAD TIP WAS FOUND PARTLY SEPARATED FROM THE LEAD BODY AND THE FIXATION HELIX WAS FOUND BEND AND DEFORMED. THESE DAMAGES REQUIRE EXTRAORDINARY MECHANICAL FORCES WHICH RESULTED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT SHOW ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT VENTRICULAR LEAD WAS EXHIBITING HIGH THRESHOLD MEASUREMENTS AND LOW IMPEDANCE MEASUREMENT. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization