BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 3242415 · Received July 23, 2013

    Report

    Report Number
    2649622-2013-08240
    Event Type
    Death
    Date Received
    July 23, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. PRODUCT EVENT SUMMARY: (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TOFLEXING WHILE IN VIVO. THE INNER INSULATION OF THE LEAD DEVELOPED COSMETIC (MIO) METAL ION OXIDATION WHILE IN VIVO, AND THE OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO. THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. CONCOMITANT PRODUCTS: SDR303B IMPLANTABLE PULSE GENERATOR (IPG), IMPLANTED: (B)(6 )2001; 4068-58 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2001. (B)(4).

    Description of Event or Problem · 1

    THE LEADS WERE RETURNED TO THE MANUFACTURER WITH NO INFORMATION, WERE ANALYZED AND TESTED OUT OF SPECIFICATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY SIX YEARS AFTER LEAD IMPLANT AND GREATER THAN FIVE YEARS PRIOR. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342271 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 Death