BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 5122488 · Received October 2, 2015

    Report

    Report Number
    2649622-2015-12291
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    July 18, 2015
    Report Date
    July 18, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE DAY AFTER IMPLANT, THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED AND FALLEN INTO THE RIGHT VENTRICULAR CHAMBER. THE LEAD WAS PROGRAMMED OFF UNTIL THE LEAD COULD BE REVISED THE FOLLOWING DAY. THE LEAD WAS REPOSITIONED. AFTER THE RA LEAD WAS REPOSITIONED, THE RIGHT VENTRICULAR (RV) LEAD SHOWED A HIGH THRESHOLD. THE RV LEAD WAS ALSO REPOSITIONED. BOTH 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
    653609 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R 5076-52 LEAD, RVDR01 IPG