BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE EPI

    MDR report key: 2021017 · Received March 16, 2011

    Report

    Report Number
    2182208-2011-00442
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    August 30, 2006
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE LEAD MODEL 6949 IS PART OF THE ADVISORY.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THAT THE PATIENT IMPLANTED WITH THE RIGHT VENTRICULAR LEAD "SUFFERED PHYSICAL AND OTHER INJURY, INCLUDING AN UNTIMELY AND WRONGFUL DEATH". APPROXIMATELY THREE YEARS LATER, AN ALLEGATION FROM A SECOND ATTORNEY INDICATED THE PATIENT IMPLANTED WITH A RIGHT VENTRICULAR LEAD IS DECEASED AND NO FURTHER INFORMATION WAS PROVIDED. FURTHER REVIEW OF THE EVENT AND MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED APPROXIMATELY TWENTY-SEVEN DAYS POST REPLACEMENT OF THE DEVICE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death