BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4102934 · Received September 19, 2014

    Report

    Report Number
    2649622-2014-10362
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S PARENT THAT THE VENTRICULAR LEAD ¿IS NOT WORKING¿ AND NEEDED TO BE REPLACED. IT WAS FURTHER REPORTED THAT THE LEAD HAD ¿MALFUNCTIONED AND THAT THE XRAY SHOWED NO CRACKS OR DISPLACEMENT. ADDITIONAL INFORMATION OBTAINED FROM THE CARDIOLOGY CLINIC REPORTED THAT THE LEAD WAS NOT FULLY SEATED IN THE DEVICE HEADER. A LEAD REVISION WAS PERFORMED AND THE PIN WAS COMPLETED SEATED 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
    584914 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 00017 YR Hospitalization| R A2DR01 IPG, 5086MRI-45