BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 2122538 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07876
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S11
    Removal / Correction Number
    ASKU
    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 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 PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. AN INNER INSULATION BREACH METAL IRON OXIDATION WAS NOTED. THE PROXIMAL CONDUCTOR WAS FOUND TO BE DISTORTED AND CUT. OUTER INSULATION COSMETIC ENVIRONMENTAL STRESS CRACKING WAS NOTED AND ALL INSULATORS WERE BREACHED CUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS WERE RETURNED WITH NO INFORMATION, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED ASSOCIATED WITH THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4004M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 8416 IMPLANTABLE PULSE GENERATOR