BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1925143 · Received December 14, 2010

    Report

    Report Number
    2182208-2010-00992
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 28, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DYB
    PMA / PMN Number
    K080500
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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): THE FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES. THE PROXIMAL CONDUCTOR WAS DISTORTED, BLOOD WAS IN/ON THE HELIX, THE LEAD WAS STRETCHED AND THERE WAS IMPLANT DAMAGE. (B)(4) THE CATHETER WAS ANALYZED AND WAS FOUND TO BE KINKED. THE ANALYST NOTED THAT THE TIP IS TORN AS IF CAUGHT ON SOMETHING AND WAS DAMAGED AT IMPLANT. THE CATHETER WAS SLIT AND THERE WAS BLOOD VISIBLE ON THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT ATRIAL (RA) LEAD WAS DIFFICULT TO FIXATE. IT WAS DISCOVERED THAT THE CATHETER WAS KINKED OUTSIDE THE ACCESS SITE WHICH MADE IT DIFFICULT TO TORQUE THE RA LEAD. WHEN REMOVING THE CATHETER THE HELIX OF THE RA LEAD WAS STUCK AND THE PHYSICIAN "USED A LOT OF TORQUE AND MANIPULATION TO REMOVE IT". THE RA LEAD WAS NOT USED. THE CATHETER WAS REMOVED. 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 81 YR Other