BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3910108 · Received July 2, 2014

    Report

    Report Number
    2649622-2014-07620
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    June 8, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE FUNERAL HOME AND NOTED THE CAUSE OF DEATH AS: INTERSTITIAL LUNG DISEASE- IMMEDIATE CAUSE, METASTATIC PROSTATE CANCER- DUE TO OR AS A CONSEQUENT OF, CHRONIC OBSTRUCTIVE LUNG DISEASE- OTHER SIGNIFICANT CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY ELEVEN MONTHS POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. THE MANUFACTURER¿S REPRESENTATIVE WAS CONTACTED BY HOSPITAL STAFF TO HAVE DEVICE PACING TURNED OFF PER FAMILY REQUEST AFTER THE PATIENT HAD EXPIRED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387265 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Death C4TR01 IPG, 4296-88 LEAD