BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 2052298 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-07133
    Event Type
    Death
    Date Received
    April 12, 2011
    Date of Event
    January 7, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. THE DEVICES WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION AND FURTHER THIS PATIENT DIED TENS YEARS AGO. CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. IT WAS NOTED THE OUTER INSULATION WAS BREACHED (ENVIRONMENTAL STRESS CRACKING), PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC (ENVIRONMENTAL STRESS CRACKING), AND VISUAL ANALYSIS PERFORMED ONLY.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THE LEAD WAS RETURNED WITH NO INFORMATION. REVIEW OF THE MANUFACTURER'S DATABASE REVEALED, THE PATIENT DIED APPROXIMATELY TEN YEARS FROM THE LEAD IMPLANT. NO FURTHER INFORMATION WILL BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death 5034 IMPLANTABLE PACING LEAD