BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4160121 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12022
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT: 5086MRI45 LEAD IMPLANTED 2014-(B)(6). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT AFTER THEIR IMPLANT PROCEDURE, THEY EXPERIENCED PAIN AND SWELLING IN THE LEFT ARM, AND THAT THEY COULD FEEL THEIR LEADS "MOVE" AND "BUCKLE UP" BEHIND THEIR DEVICE WHEN RECLINING. IT WAS FURTHER REPORTED THAT AN ULTRASOUND TEST REVEALED A BLOOD CLOT IN THE PATIENT'S SUBCLAVIAN VEIN. THE PATIENT WAS STARTED ON ANTICOAGULANT MEDICINE. THE DEVICE AND LEADS REMAIN 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
    637999 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Life Threatening| R A2DR01 IPG