BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2171939 · Received July 22, 2011

    Report

    Report Number
    2649622-2011-10862
    Event Type
    Death
    Date Received
    July 22, 2011
    Date of Event
    June 20, 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
    IN, 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

    IT WAS REPORTED THAT THE PATIENT DEVELOPED SLOW VENTRICULAR TACHYCARDIA WHICH WAS IN AND OUT OF THE DETECTION ZONE. THE DEVICE DID NOT DETECT THE ARRHYTHMIA AND THERAPY WAS DELAYED. THE PATIENT EXPIRED DUE TO CARDIAC ARREST. FURTHER DETAILS SURROUNDING THE DEATH HAVE 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 71 YR Death| O