BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2042683 · Received April 6, 2011

    Report

    Report Number
    2649622-2011-04415
    Event Type
    Death
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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

    IT WAS REPORTED THAT A PATIENT WHO HAD AN IMPLANTABLE CARDIAC DEFIBRILLATOR DIED. THERE WAS A REPORT THAT THERE WAS OVERSENSING THAT OCCURRED RESULTING IN A NON SUSTAINED TACHYCARDIA EPISODE. THE T-WAVE OVERSENSING RESOLVED AND THE PATIENT RETURNED TO PACING. THIS EPISODE OCCURRED TWELVE DAYS PRIOR TO THE DAY OF DEATH. ON THE DAY OF DEATH AN AGONAL RHYTHM WAS RECORDED. CAUSE OF DEATH HAD BEEN REQUESTED AND NOT RECEIVED.

    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 84 YR Death