BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR

    MDR report key: 2203477 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01530
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 6, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    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. 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, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL HOURS AFTER IMPLANT OF A NEW PACEMAKER, IT WAS NOTED THAT THERE WAS NO PACING CAPTURE IN THE ATRIUM. THE PATIENT WAS BROUGHT BACK IN FOR A REVISION. INITIAL DETERMINATION WAS THOUGHT TO BE LEAD DISLODGEMENT, BUT TESTING USING THE ANALYZER INDICATED THAT THERE WERE LOW THRESHOLDS ON THE DEVICE. THE DEVICE WAS REMOVED 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
    1 ADVISA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. A5DR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R