BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR

    MDR report key: 2608113 · Received June 11, 2012

    Report

    Report Number
    6000094-2012-01120
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    March 19, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE DEVICE WAS NOT PACING PROPERLY WHEN CONNECTED TO THE LEADS. THE LEADS WERE DISCONNECTED FROM THE DEVICE AND TESTED WITH THE ANALYZER; LEAD MEASUREMENTS WERE GOOD. THE DEVICE WAS THEN RECONNECTED TO THE LEADS BUT WAS AGAIN NOT PACING PROPERLY. THE DEVICE WAS REMOVED AND A DIFFERENT DEVICE WAS SUCCESSFULLY IMPLANTED. 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