BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4963402 · Received August 4, 2015

    Report

    Report Number
    2649622-2015-07836
    Event Type
    Death
    Date Received
    August 4, 2015
    Date of Event
    June 24, 2013
    Report Date
    July 7, 2015
    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: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED. VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM A CREMATORY WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. (B)(4).

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A CREMATORY WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY 3 MONTHS AFTER THE DEVICE SYSTEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507453 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death