BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3862506 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01369
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT: PRODUCT ID 5086MRI58 LEAD IMPLANTED: 2014-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PACING FAILURE AT MIDNIGHT WAS OBSERVED ON ELECTROCARDIOGRAM (ECG) DATA, AND THE DEVICE CHECK WAS PERFORMED. IT WAS NOTED THERE WAS VENTRICULAR OVERSENSING AT HOURLY INTERVALS OBSERVED. IT TURNED OUT TO BE AN OVERSENSING WHILE SAVING EGM. THE DEVICE SENSITIVITY WAS CHANGED. THE DEVICE 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
    339470 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5086MRI52 LEAD