BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2021168 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-04033
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    January 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    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. 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 FOR THIS MODEL.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT DIED APPROXIMATELY FIVE MONTHS POST IMPLANT OF THE RIGHT VENTRICULAR LEAD. FURTHER REVIEW REVEALED THE PATIENT DIED APPROXIMATELY FIVE MONTHS POST IMPLANT OF THE RIGHT ATRIAL LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AS WELL. IT WAS ALSO NOTED THE PATIENT SUFFERED EXTREME PHYSICAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death