BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3551466 · Received January 3, 2014

    Report

    Report Number
    2649622-2014-00008
    Event Type
    Death
    Date Received
    January 3, 2014
    Date of Event
    April 16, 2013
    Report Date
    January 28, 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

    PRODUCT EVENT SUMMARY # PRODUCT ID# 5076-45. A PROXIMAL PORTION WAS RECEIVED MEASURING 4 CM. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND, VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED ONLY.

    Additional Manufacturer Narrative · 1

    CLARIFICATION ON DATES FOR THE REPORTED INFORMATION WAS OBTAINED AND NOTED THE BECOMES AWARE DATE AS NOVEMBER 13, 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED AND THE PATIENT WAS IDENTIFIED AS BEING DECEASED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. HOWEVER, IF ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. CONCOMITANT MEDICAL PRODUCTS: IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR, PRODUCT ID D314TRM, IMPLANTED: (B)(6) 2012; IMPLANTABLE PACING LEAD, PRODUCT ID 419688, IMPLANTED: (B)(6) 2012; IMPLANTABLE DEFIBRILLATION LEAD, PRODUCT ID 6947M55, IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM A HISTOLOGIST WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY NINE MONTHS POST IMPLANT OF THE ICD. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THE CAUSE OF DEATH AS ISCHEMIC CARDIOMYOPATHY, CONGESTIVE HEART FAILURE AND CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4142 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death