BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3151474 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05490
    Event Type
    Death
    Date Received
    June 7, 2013
    Date of Event
    February 11, 2013
    Report Date
    June 19, 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, VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED ONLY.

    Additional Manufacturer Narrative · 1

    THIS DEVICE SYSTEM WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. NO FURTHER INFORMATION HAS BEEN OBTAINED THUS FAR THAT WOULD/COULD DISASSOCIATE THE DEVICE SYSTEM AND EVENT. THEREFORE THIS EVENT WILL BE PROCESSED WITH THE INFORMATION AT HAND AND WILL BE CAPTURED AS A MEDICAL/DEATH ON INCOMING INFORMATION. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. HOWEVER, IF ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. PRODUCT ID (B)(4) IMPLANTED: (B)(6) 2013; PRODUCT ID (B)(4) IMPLANTED: (B)(6) 2013. (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 CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY ONE MONTH POST IMPLANT OF THE ICD SYSTEM. A CAUSE OF DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252534 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death