BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2182208-2014-01772

    MDR report key: 3863502 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01772
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 6949-58 LEAD IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CORONARY SINUS DISSECTION OCCURRED WHILE TRYING TO CANNULATE THE CORONARY SINUS BY USING A CATHETER AND A GUIDEWIRE. THE LEFT VENTRICULAR (LV) LEAD DELIVERY <(>&<)> PLACEMENT WAS NOT ACHIEVED. THE PATIENT WILL NEED TO BE BROUGHT BACK FOR A LV LEAD IMPLANT IN THE FUTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338675 DQX MEDTRONIC, INC. MDT-GUIDEWIRE

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R 4076-45 LEAD