BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN

    MDR report key: 3153102 · Received June 8, 2013

    Report

    Report Number
    9612164-2013-00614
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K080428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE CATHETER DISSECTED THE PATIENT¿S CORONARY SINUS. THE PROCEDURE WAS FINISHED SUCCESSFULLY AND NO FURTHER ACTION WAS NECESSARY. THE PATIENT FEELS WELL AND HAS HAD NO PROBLEMS. BLOOD TESTS AND X-RAYS WERE NORMAL. THE PATIENT IS ENROLLED IN THE (B)(4) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255982 ATTAIN CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6250C02 0006550318

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L