BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152268 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06884
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN CRITICIZED THE LONGEVITY OF THE DEVICE AS IT ONLY WORKED FOR 3 YEARS AND 9 MONTHS. THE PROGRAMMED PARAMETERS WERE NORMAL WITH TWO PAST THERAPIES DELIVERED AND MANY MODE SWITCHES. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD P-WAVES WERE VARYING, HOWEVER THE PATIENT HAS ATRIAL FIBRILLATION. IT WAS ALSO NOTED THAT THE VENTRICULAR R WAVE SENSING WAS A BIT LOW. THE DEVICE WAS EXPLANTED AND REPLACED, THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252949 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR