BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2103165 · Received May 25, 2011

    Report

    Report Number
    2649622-2011-07652
    Event Type
    Death
    Date Received
    May 25, 2011
    Date of Event
    May 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    A PATIENT WITH SIGNIFICANT MEDICAL HISTORY WAS IMPLANTED WITH AN IMPLANTABLE GENERATOR SYSTEM AND EXPIRED IN THE RECOVERY ROOM SOON AFTER THE IMPLANT. THE PATIENT SUFFERED A RECENT MYOCARDIAL INFARCTION AND SUFFERED FROM CONGESTIVE HEART FAILURE. DURING THE IMPLANT THE RIGHT VENTRICULAR LEAD HAD TO BE REPOSITIONED DUE TO HIGH THRESHOLDS. THE OFFICIAL CAUSE OF DEATH IS LISTED AS PERICARDIAL EFFUSION, TAMPONADE.

    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 85 YR Death| H| L| R