BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4161721 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11433
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 WAS RETURNED IN SEGMENTS. ANALYSIS INDICATED THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. THE ANALYST NOTED THAT THE PRESENCE OF A LEAD REMOVAL WIRE PREVENTED ELECTRICAL CONTINUITY TESTING. VISUAL CONTINUITY INSPECTION WAS PERFORMED FOR ENTIRE CONDUCTOR LENGTH USING DESTRUCTIVE TESTING. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN MODEL COMPETITOR IPG; IMPLANT: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED WITH NO INFORMATION PROVIDED WITH THE RETURN. FOLLOW-UP REVEALED THAT THIS IMPLANTABLE PACING LEAD ALONG WITH THE COMPETITIVE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD WERE REMOVED DUE TO POCKET INFECTION WITH EROSION. THE PATIENT CURRENTLY DOES NOT HAVE PACEMAKER SYSTEM IMPLANTED. THE LEAD WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639037 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 4457, COMPETITOR LEAD