BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN COMMAND

    MDR report key: 3860748 · Received June 10, 2014

    Report

    Report Number
    9612164-2014-00582
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K080428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE CATHETER WAS RETURNED, ANALYZED, AND THE MECHANICAL OPERATION OF THE CATHETER PEELING/SLITTING/SPLITTING SHOWED A SPIRAL SLIT. IT WAS ALSO NOTED THAT THE MECHANICAL OPERATION OF THE CATHETER SHAFT WAS BENT, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST COMMENTED THAT THE CATHETER IS SPIRALLY SLIT TO 7CM FROM THE HANDLE, THEN SLITTING STOPS. SPIRAL SLITTING (TECHNIQUE ISSUE) STARTS RIGHT FROM THE BEGINNING AND SNAGS (STRESS CRACKING VISIBLE) AT 1 AND 3CM, WHEN IT STOPS AT 7CM.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN WAS NOT ABLE TO SLIT TWO DIFFERENT CATHETERS BECAUSE THE SLITTER JUMPED OUT. A DIFFERENT CATHETER WAS USED TO SUCCESSFULLY DELIVER THE LEFT VENTRICULAR (LV) LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336881 ATTAIN COMMAND CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6250MB202 0006846100

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR