BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4970150 · Received August 5, 2015

    Report

    Report Number
    2649622-2015-08669
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 12, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 PATIENT EXPERIENCED CHEST DISCOMFORT. IT WAS DISCOVERED THAT THE PATIENT HAD A PERFORATION AND THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD INCREASING THRESHOLDS AND THE PATIENT FELT RV PACING AT HIGHER THRESHOLDS. THE RV LEAD WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512668 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| L| R 5076-52 LEAD, A2DR01 IPG