BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR

    MDR report key: 2864908 · Received December 10, 2012

    Report

    Report Number
    9614453-2012-00246
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    DXY
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE "MISSING VENTRICULAR BEATS" OBSERVED WITHIN FORTY-EIGHT HOURS OF THE DEVICE IMPLANT. THE VENTRICULAR SENSITIVITY WAS REPROGRAMMED AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVISA DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC S.A. (SMO) A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention 5086MRI X 2 IMPLANTABLE PACING LEADS