BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSITE DEFLECTABLE CATH

    MDR report key: 1854712 · Received October 5, 2010

    Report

    Report Number
    2182208-2010-00668
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQY
    PMA / PMN Number
    K033989
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. ANALYSIS OF THE CATHETER IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEFLECTABLE SHEATH WAS DAMAGED DURING IMPLANTATION OF A CARDIAC PACING LEAD. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTSITE DEFLECTABLE CATH LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC, INC. C304S59 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other