BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3864668 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07410
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 MEDICAL PRODUCTS: 5086MRI52 LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HEART RATE WAS IN THE UPPER FORTIES AND LOWER FIFTIES CAUSING THE PATIENT TO HAVE NO ENERGY AND FALL ASLEEP A LOT. THE RIGHT ATRIAL (RA) LEAD WAS FOUND TO HAVE NO CAPTURE. A LEAD REVISION IS SCHEDULED IN WHICH THE LEAD STATUS WILL BE ASSESSED. THE RA 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
    338944 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R A2DR01 IPG