BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3151916 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05584
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD IN SEGMENTS WAS RETURNED AND ANALYZED. ANALYSIS FOUND THE DISTAL CONDUCTOR FLEXED/FRACTURED. THE PROXIMAL CONDUCTOR WAS KINKED/BUCKLED. THE ANALYST COMMENTED ELECTRICAL OF DISTAL CONTINUITY TEST RESULTS WAS FAILED. PERFORMED DESTRUCTIVE ANALYSIS AND VISUAL INSPECTION OF DISTAL COIL. FRACTURE WAS OBSERVED. (B)(4) IMPLANTABLE PULSE GENERATOR 2009 (B)(6); 5076-52 IMPLANTABLE PACING LEAD 2009 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE, NOISE, AND NO CAPTURE AT MAXIMUM OUTPUT. AN INNER COIL FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252341 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R