BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 2072251 · Received April 28, 2011

    Report

    Report Number
    2649622-2011-07359
    Event Type
    Death
    Date Received
    April 28, 2011
    Date of Event
    April 11, 2010
    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. EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. IT WAS NOTED THERE WAS OUTER INSULATION BREACHED (ENVIRONMENTAL STRESS CRACKING), ALL CONDUCTORS STRETCHED, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC (ENVIRONMENTAL STRESS CRACKING), INNER INSULATION TORN, OUTER INSULATION BREACHED CUT, OUTER INSULATION COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED AND RETURNED TO THE MANUFACTURER WITH NO INFORMATION AFTER THE PATIENT'S DEATH. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THE PATIENT DIED APPROXIMATELY THIRTEEN YEARS FROM LEAD IMPLANT. NO FURTHER INFORMATION IS 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 82 YR Death E2DR01 IMPLANTABLE PULSE GENERATOR| 4068 IMPLANTABLE PACING LEAD