BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2021132 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-03996
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    November 6, 2006
    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
    TX, 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 6949 LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES FOR WHICH THEY ARE ENTITLED TO COMPENSATORY AND EQUITABLE DAMAGES AND DECLARATORY RELIEF IN AN AMOUNT TO BE PROVEN AT TRIAL." APPROXIMATELY THREE YEARS LATER, AN ALLEGATION FROM THE SAME LAW FIRM INDICATED THAT THE PATIENT DIED AND NO FURTHER INFORMATION WAS PROVIDED. FURTHER ASSESSMENT OF THE MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST IMPLANT OF THE IMPLANTABLE CARDIOVERSION DEFIBRILLATION SYSTEM.

    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 70 YR Death