BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3993562 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09258
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 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
    PHYSICIAN

    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 PRODUCTS: 6947M62 LEAD, IMPLANTED: (B)(6) 2012; 419478 LEAD IMPLANTED: (B)(6) 2012; 5554-53 LEAD IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO YEARS PRIOR, THE RIGHT ATRIAL (RA) LEAD DISLODGED WITHIN A DAY AFTER IMPLANT. THE OLD RA LEAD WAS PROGRAMMED OFF BY PROGRAMMING THE DEVICE TO VVIR MODE. A NEW LEAD OF THE SAME MODEL WAS RECENTLY IMPLANTED IN THE ATRIUM AND ALSO DISLODGED A DAY AFTER IMPLANT. A THIRD BUT DIFFERENT MODEL LEAD WAS SUCCESSFULLY IMPLANTED IN THE ATRIUM AND REMAINS 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
    467079 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R DTBA2D4 BIV ICD