BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6160746 · Received December 9, 2016

    Report

    Report Number
    3008973940-2016-00926
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    UDI-DI
    00681490124867
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. IT WAS UNDETERMINED IF IT WAS CAUSED BY A LEAD OR NOT. TROUBLESHOOTING HAS NOT YET BEGUN, BUT IS PLANNED AND THE RIGHT VENTRICULAR (RV) LEAD 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
    809200 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58 00681490124867

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening A2DR01 IPG, 5076-52 LEAD