BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1926336 · Received December 14, 2010

    Report

    Report Number
    2182208-2010-01019
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 9, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    K900515
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. EVALUATION SUMMARY: (B)(4): UPON VISUAL ANALYSIS IT WAS REPORTED THAT THE INTRODUCER SHEATH WAS KINKED AND APPEARS TO HAVE SNAGGED ON SOMETHING. IT WAS NOTED THAT A SCORE LINE ON ONE SIDE WAS TORN, THAT THE ACCESSORY APPEARED DAMAGED AT IMPLANT BUT THAT THE TIP OF THE INTRODUCER APPEARED NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIFFICULTY ADVANCING THE INTRODUCER SHEATH IN LEFT SUBCLAVIAN VEIN AND THERE WAS DAMAGE TO THE SHEATH. THE SHEATH WAS RETURNED FOR ANALYSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE PERMANENT LEAD INTRODUCER DQY MEDTRONIC, INC. 6207 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 DA Other