BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 4161767 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02647
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ATRIAL LEAD PACING THRESHOLD PROBLEM. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT OCCURRENCE OF PACEMAKER ATRIAL CONNECTOR STUCK AND UNABLE TO CONNECT LEAD AGAIN. THE PACEMAKER WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639401 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 407458 LEAD