BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1924271 · Received December 14, 2010

    Report

    Report Number
    2182208-2010-00976
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 27, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DYB
    PMA / PMN Number
    K080500
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND; FULL LEAD WAS RETURNED AND ANALYZED. FURTHER TESTING REVEALED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED AND THE LEAD WAS DAMAGED AT IMPLANT. C315J CATHETER WAS KINKED. IT WAS NOTED THAT THE CATHETER WAS DAMAGED AT IMPLANT, AND THE CATHETER SHAFT KINKED AT 3CM FROM THE HUB. C315S5 CATHETER WAS KINKED. IT WAS NOTED THAT THE CATHETER WAS DAMAGED AT IMPLANT, AND THE CATHETER IS KINKED AT 27CM FROM THE HUB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD POSITIONING WAS ATTEMPTED IN THE RIGHT ATRIUM WITH VARIOUS CATHETERS AND WAS NOT SUCCESSFUL. IT WAS FURTHER REPORTED THAT PATIENT'S PRIOR VALVE SURGERY ALSO CONTRIBUTED TO THE DIFFICULTIES. A DIFFERENT LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU LEFT HEART DELIVERY SYSTEM DYB MEDTRONIC, INC. C315J ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other