BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 1061574 · Received June 11, 2008

    Report

    Report Number
    2649622-2008-03250
    Event Type
    Death
    Date Received
    June 11, 2008
    Date of Event
    February 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. FOLLOWUP DID NOT OFFER ANY ADDITIONAL INFORMATION THEREFORE WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE DEVICES HAVE SINCE BEEN RECIEVED BY THE MANUFACTURER. DETAILED ANALYSIS OF THE DEVICE WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB