BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3991556 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02136
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PHYSICIAN HAS HAD GENERAL ISSUES WITH THE MRI PACING LEADS, WHICH INCLUDES MICRODISLODGEMENT ISSUES, HIGH THRESHOLDS POST-IMPLANT AND HIGHER THAN USUAL IMPEDANCE VALUES AT IMPLANT. NO SPECIFIC PATIENTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470498 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 5086

    Patients

    Seq Age Sex Outcome Treatment
    1