BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 4970669 · Received August 5, 2015

    Report

    Report Number
    2649622-2015-08415
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    April 13, 2015
    Report Date
    June 19, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE WITH 1 OF 5 PROXIMAL FILARS CUT. CONCOMITANT PRODUCT: 5076-45 LEAD IMPLANTED: (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED AND REPLACED DUE TO A SYSTEM UPGRADE. 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
    514178 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R ADDR01 IPG