BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3861452 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07275
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 13, 2014
    Report Date
    March 4, 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

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. PRODUCTS: 5076-45 LEAD IMPLANTED: 2004 (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER WITH NO INFORMATION. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343315 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R (B)(4) IPG