BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD STYLET KIT

    MDR report key: 2952016 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00120
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 11, 2012
    Report Date
    November 28, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DRB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. PRODUCT EVENT SUMMARY: THE FULL ACCESSORY WAS RETURNED AND ANALYZED. THE GUIDEWIRE WAS FOUND TO BE KINKED/BUCKLED, AND APPEARED TO HAVE BEEN DAMAGED AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, IT WAS NOT POSSIBLE TO INSERT THE GUIDEWIRE INTO THE LEAD, AS THE TIP APPEARED TO BE CROOKED. THE GUIDEWIRE WAS NOT USED, AND THE LEAD WAS IMPLANTED USING ANOTHER GUIDEWIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57610 LEAD STYLET KIT STYLET, CATHETER DRB RICE CREEK MFG 6093

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR