BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3232624 · Received July 18, 2013

    Report

    Report Number
    2649622-2013-08215
    Event Type
    Death
    Date Received
    July 18, 2013
    Report Date
    July 23, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. CONCOMITANT PRODUCTS: 694765 IMPLANTABLE TACHY LEAD IMPLANTED: 2004 (B)(6); (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  IMPLANTED: 2012 (B)(6); 419488 IMPLANTABLE PACING LEAD IMPLANTED: 2005 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL INDICATED THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AFTER A RECENT DIAGNOSIS OF ALVEOLAR HEMORRHAGE THOUGHT TO BE AUTOIMMUNE ON CHRONIC STEROID USE. THE PATIENT WAS FOUND TO HAVE A NEW CAVITARY LESION ON THE RIGHT MIDDLE LOBE AS WELL AS BILATERAL INFILTRATES THOUGHT TO BE OF INFECTIOUS ETIOLOGY. THE PATIENT DEVELOPED ACUTE HYPOXIC RESPIRATORY FAILURE AND THE DECISION WAS MADE TO PLACE THE PATIENT ON COMFORT CARE MEASURES ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT TRIGGERED, AND THE PATIENT RECEIVED A SHOCK. ADDITIONAL INFORMATION RECEIVED IN FOLLOW UP NOTED THAT THE PATIENT IS DECEASED AND DIED APPROXIMATELY SIX WEEKS POST PATIENT ALERT. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SIX MONTHS POST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333811 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L