BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN

    MDR report key: 1874617 · Received October 19, 2010

    Report

    Report Number
    2182208-2010-00817
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 29, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DYG
    PMA / PMN Number
    K012225
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. NOTE: AN ADDITIONAL GUIDE CATHETER WAS RETURNED AND ANALYZED. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE LEAD APPEARED DAMAGED AT IMPLANT AND THE LEAD WAS STRETCHED. 6215: ANALYSIS REVEALED NO ANOMALIES. 6216A: ANALYSIS REVEALED NO ANOMALIES. THE 4193 LEAD RETURNED PASSES THROUGH THIS GUIDE CATHETER WITHOUT ISSUE. 2ND 6216A: ANALYSIS OF THIS GUIDE CATHETER REVEALED THAT CATHETER IS KINKED AT VARIOUS LOCATIONS AND APPEARS DAMAGED AT IMPLANT. BLOOD IS VISIBLE ON THE CATHETER. THE 4193 LEAD RETURNED WOULD NOT PASS THROUGH THIS CATHETER DUE TO KINKS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEFT VENTRICULAR LEAD COULD NOT BE POSITIONED IN THE TARGET VESSEL. THE LEAD WAS REMOVED AND RETURNED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN LEFT HEART DELIVERY SYSTEM DYG MEDTRONIC, INC. 6215 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other| R