BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1810597 · Received August 23, 2010

    Report

    Report Number
    2649622-2010-08863
    Event Type
    Death
    Date Received
    August 23, 2010
    Date of Event
    July 1, 2010
    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
    ND, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL FOR LEAD EXTRACTION DUE TO ENDOCARDITIS, SEPSIS, AND VEGETATION ON VALVES. THE DEVICE AND LEADS WERE ALL EXTRACTED "RATHER EASILY AND DID NOT REQUIRE LASER EXTRACTION." UPON TRANSFER TO THE PATIENT ROOM, THE PATIENT BECAME PALE, HAD DIFFICULTY BREATHING, AND SUBSEQUENTLY HAD A VENTRICULAR FIBRILLATION ARREST AND DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CULTURES WERE REPORTED TO HAVE BEEN CANCELLED DUE TO THE PATIENT DEATH.

    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 76 YR Death