BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3861447 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07277
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PRODUCT: RVDR01 IPG, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS CHECKED RECENTLY AND THERE WAS APPARENT NOISE RECORDED ON BOTH THE STORED ATRIAL AND VENTRICULAR EPISODES. THE PHYSICIAN WAS UNABLE TO REPRODUCE THE NOISE IN OFFICE. THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD REMAIN 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
    342406 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 00085 YR 5086MRI52 LEAD