BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3010608 · Received March 19, 2013

    Report

    Report Number
    2649622-2013-02531
    Event Type
    Death
    Date Received
    March 19, 2013
    Date of Event
    September 2, 2012
    Report Date
    April 8, 2013
    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

    PRODUCT EVENT SUMMARY: (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). CONCOMITANT PRODUCT: 6949 IMPLANTABLE TACHY LEAD 2006 (B)(6).

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH INFORMATION NOTING THE PATIENT IS DECEASED. THE CAUSE OF DEATH WAS PROVIDED AS CARDIORESPIRATORY ARREST AND SEPTIC SHOCK. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SIX YEARS AFTER DEVICE SYSTEM IMPLANTED. ADDITIONAL CIRCUMSTANCES RELATED TO THE CAUSE OF DEATH AND THE SOURCE OF THE SEPSIS HAVE BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH INFORMATION NOTING THE PATIENT IS DECEASED. THE CAUSE OF DEATH WAS PROVIDED AS CARDIORESPIRATORY ARREST AND SEPTIC SHOCK. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SIX YEARS AFTER DEVICE SYSTEM IMPLANTED. ADDITIONAL CIRCUMSTANCES RELATED TO THE CAUSE OF DEATH AND THE SOURCE OF THE SEPSIS HAVE BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114954 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR