BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 4160895 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11724
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 5, 2005
    Report Date
    July 11, 2014
    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 FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE INNER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO MIO (METAL ION OXIDATION) WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO MIO (METAL ION OXIDATION) WHILE IN VIVO. THE INNER AND OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC (MIO) METAL ION OXIDATION WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO. CONCOMITANT PRODUCT: KDR401 IPG, (B)(6) 1998. (B)(4).

    Description of Event or Problem · 1

    THE PREVIOUSLY CAPPED LEAD WAS ELECTIVELY EXPLANTED DURING A DEVICE REPLACEMENT PROCEDURE. FOLLOW UP INDICATED THAT THE LEAD WAS INITIALLY CAPPED DUE TO A DROP IN IMPEDANCE SUGGESTING LEAD FAILURE SECONDARY TO INSULATION BREACH. IT WAS NOTED THAT DURING THE LEAD REPLACEMENT PROCEDURE, THE LEAD HAD NO CAPTURE AT MAXIMUM OUTPUTS. THE LEAD WAS RETURNED TO THE MANUFACTURER 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
    642434 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Hospitalization| R 4592-53 LEAD