BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 7254047 · Received February 8, 2018

    Report

    Report Number
    2649622-2018-00460
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    December 7, 2017
    Report Date
    February 8, 2018
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169633759
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: 3889-28 MGU LEAD, IMPLANTED: (B)(6) 2013; 3058 MGU IPG, IMPLANTED: (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND NO CAPTURE. THE RV LEAD WAS REPOSITIONED 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
    99191 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00643169633759

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R