BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 2810979 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15820
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    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 RETURN AND 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. EVALUATION SUMMARY: (B)(4). THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE PRIMARY FINDING WAS INNER INSULATION HAD BREACHED METAL ION OXIDATION (MIO). BLOOD/BODY FLUID WAS OBSERVED ON THE TIP ELECTRODE AND ON ALL CONDUCTORS. THE PROXIMAL CONDUCTOR WAS DISTORTED. THE OUTER INSULATION WAS KINKED/BUCKLED, MELTED, BREACHED/CUT AND HAD COSMETIC AND BREACHED ENVIRONMENTAL STRESS CRACKING (ESC). THE OUTER INSULATION ALSO HAD A COSMETIC DEPRESSION AND COSMETIC MIO. THE INNER INSULATION HAD COSMETIC MIO. THE INNER INSULATION WAS TORN. (B)(4). THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE PRIMARY FINDING WAS THE INNER INSULATION HAD BREACHED MIO. BLOOD WAS OBSERVED IN/ON THE HELIX/LOBE MECHANISM, SLEEVE HEAD AND ALL CONDUCTORS. THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL. THE PROXIMAL CONDUCTOR WAS DISTORTED. THE INNER INSULATION HAD COSMETIC MIO. THE OUTER INSULATION HAD COSMETIC ESC, A COSMETIC DEPRESSION AND WAS BREACHED/CUT.

    Description of Event or Problem · 1

    THE LEADS WERE ELECTIVELY REPLACED DUE TO A SYSTEM UPGRADE. THE LEADS WERE RETURNED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB