BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ACCESS

    MDR report key: 1992540 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00194
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    September 10, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    K012130
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, A VENOGRAPHY AFTER THE CANNULATION OF THE CORONARY SINUS SHOWED A SMALL DISSECTION NEAR THE OSTIUM. THE PHYSICIAN TRIED FOR A BETTER LOCATION FOR THE GUIDE CATHETER, BUT IT WAS NOT POSSIBLE: THE NEW VENOGRAPHY SHOWED PERICARDIAL EFFUSION AROUND THE WHOLE HEART. THE IMPLANT CONTINUED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ACCESS LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC, INC. 6216 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R