BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3992637 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09752
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5076-52 LEAD, IMPLANTED (B)(6) 2010. (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: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD WAS ALSO OBSERVED TO HAVE BLOOD INGRESSION. VISUAL ANALYSIS FOUND OUTER INSULATION BREACHED IN-VIVO/DEPRESSION. THE BREACHED INSULATION DID CONTRIBUTE TO THE ELECTRICAL COMPLAINT OF HIGH THRESHOLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH THRESHOLD LEVELS WERE OBSERVED ON THE PATIENT'S RIGHT ATRIAL (RA) LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470156 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R ADDR01 DEVICE