BEUDAMED
    FDA Adverse Event Death Summary report: N

    BCAPSUREFIX NOVUS

    MDR report key: 2160432 · Received July 13, 2011

    Report

    Report Number
    2649622-2011-10841
    Event Type
    Death
    Date Received
    July 13, 2011
    Date of Event
    October 20, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 BY A STUDY THAT THE PATIENT WAS DECEASED. THE PATIENT'S DEATH OCCURRED LESS THAN ONE YEAR AFTER IMPLANT. FOLLOW UP HAS BEEN INCONCLUSIVE SO FAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. NO COMPLAINTS OR ALLEGATIONS HAVE BEEN MADE AGAINST THE DEVICE SYSTEM OR ANY OF ITS INDIVIDUAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BCAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| O