BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3170214 · Received June 14, 2013

    Report

    Report Number
    2649622-2013-08096
    Event Type
    Death
    Date Received
    June 14, 2013
    Date of Event
    July 4, 2010
    Report Date
    September 27, 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

    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. PRODUCT ID: D224DRG, (B)(6) IMPLANTED: 2009. PRODUCT ID: 6945-65, IMPLANTED: (B)(6) 2002. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: A PROXIMAL PORTION WAS RECEIVED MEASURING 22.5 CM. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM THE (B)(6) MEDICAL EXAMINER WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE PAPERWORK INDICATED THE PATIENT DIED LESS THAN ONE YEAR POST IMPLANT OF THE ICD. A CAUSE OF DEATH IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270699 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death