BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN

    MDR report key: 2123860 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08190
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    August 24, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DQY
    PMA / PMN Number
    K061480
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINOR CORONARY SINUS DISSECTION OCCURRED DURING IMPLANT. THE DISSECTION WAS NOTED ON THE VENOGRAM AND WAS READILY CIRCUMVENTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC PUERTO RICO, INC. 6227DEF ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R