BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1862805 · Received October 9, 2010

    Report

    Report Number
    2182208-2010-00765
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 29, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE J STYLETS WOULD NOT HOLD ITS SHAPE MAKING IT DIFFICULT TO INSERT THE LEAD. THE 4076 LEAD WAS NOT USED AS A RESULT OF THE STYLET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE J STYLETS WOULD NOT HOLD ITS SHAPE MAKING IT DIFFICULT TO INSERT THE LEAD. THE LEAD REMAINS IN USE. 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| R