BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3992703 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09724
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: PRODUCT ID 5068-45 LEAD, IMPLANTED: (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BECAME UNWELL AND PRESENTED TO THE HOSPITAL. THE DEVICE WAS OPERATING AT 30 BEATS PER MINUTE; HOWEVER, THE DEVICE SETTING WAS DDD60/120 PACES PER MINUTE. THE MEDICAL ENGINEER INCREASED THE OUTPUTS FROM 2 VOLTS TO 3 VOLTS WHICH HELPED THE PATIENT¿S HEART RATE RETURN TO NORMAL. THE PHYSICIAN STATED THAT THE RIGHT VENTRICULAR (RV) LEAD THRESHOLDS HAD PROBABLY INCREASED AND THE OUTPUTS ON THE RV LEAD WERE INCREASED TO 3.5 VOLTS AND VENTRICULAR CAPTURE MANAGEMENT WAS CHANGED FROM ADAPTIVE TO MONITOR. THE PATIENT WAS ADMITTED TO THE HOSPITAL PENDING ANOTHER DEVICE CHECK. THE DEVICE REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471265 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR Hospitalization| R ADDR01 IPG