BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR

    MDR report key: 2781644 · Received October 10, 2012

    Report

    Report Number
    6000094-2012-01908
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    January 5, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOLTER MONITOR WAS USED FOR 24 HOURS POST-IMPLANT, AS IS STANDARD OF CARE FOR THE HOSPITAL. IT WAS REPORTED THAT THE MONITOR SHOWED ONE P-WAVE THAT WAS BLOCKED, WITH NO CAPTURE OR OUTPUT SEEN FOR THE TIME THAT THE P-WAVE SHOULD HAVE OCCURRED. THE LEAD ELECTRICAL MEASUREMENTS WERE RE-PERFORMED, WITH ALL MEASUREMENTS OK. 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
    1 ADVISA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 5086MRI X2 IMPLANTABLE PACING LEADS