BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1920800 · Received December 13, 2010

    Report

    Report Number
    2182208-2010-00916
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    August 31, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    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): THE FULL LEAD WAS RECEIVED AND ANALYZED. ANALYSIS RESULTS REVEALED THERE WERE NO ANOMALIES FOUND. THERE WAS DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE HYBRID STYLET WAS SEEN ON X-RAY TO EXIT THE SIDE OF THE LEAD THROUGH THE WALL. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE STYLET DRB MEDTRONIC, INC. STYLET ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other