BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 3863081 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01660
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 18, 2013
    Report Date
    July 26, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 THE INITIAL ATTEMPT TO IMPLANT THE LEFT VENTRICULAR (LV) LEAD VIA THE CORONARY SINUS WAS UNSUCCESSFUL AND REQUIRED AN EPICARDIAL LEAD PLACEMENT. FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. THE LEAD WAS EXPLANTED AND LATER REPLACED. THE PATIENT WAS ENROLLED IN THE OPTI LINK HF CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340508 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R