BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNET, TEST, PACEMAKER

    MDR report key: 3617704 · Received February 8, 2014

    Report

    Report Number
    2182208-2014-00464
    Event Type
    Injury
    Date Received
    February 8, 2014
    Date of Event
    November 14, 2013
    Report Date
    November 29, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 THE LEFT VENTRICULAR LEAD DISLODGED. THE PHYSICIAN ELECTED TO REPLACE THE LEAD. DURING THE LEAD REPLACEMENT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ACCESSING THE CORONARY SINUS. WHEN THE LEAD CATHETER WAS CHANGED, THE SUPERIOR VENA CAVA VEIN WAS UNINTENTIONALLY DISSECTED. IT WAS NOT KNOWN IF THE DISSECTION WAS CAUSED BY THE CATHETER OR THE INTRODUCER. THE DISLODGED LEAD WAS REMOVED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81549 MAGNET, TEST, PACEMAKER DTG MEDTRONIC, INC. MDT-SLITTER

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| L| R