BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2131899 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00924
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    July 19, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ASKU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PLEURAL EFFUSION RELATED TO THE USE OF THE LEAD IMPLANT TOOL. FOLLOW UP WAS PERFORMED BUT NO INFORMATION WAS RECEIVED ABOUT THE IMPLANT TOOL MODEL AND WHAT ACTION WAS TAKEN. IT WAS FURTHER REPORTED THAT THE PLEURAL EFFUSION WAS NOT RELATED TO THE IMPLANT TOOL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PLEURAL EFFUSION RELATED TO THE USE OF THE LEAD IMPLANT TOOL. FOLLOW UP WAS PERFORMED BUT NO INFORMATION WAS RECEIVED ABOUT THE IMPLANT TOOL MODEL AND WHAT ACTION WAS TAKEN. 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 ASKU ASKU DQY MEDTRONIC, INC. ACCESSORY ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R