BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN COMMAND

    MDR report key: 3991398 · Received August 8, 2014

    Report

    Report Number
    9612164-2014-01043
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K080428
    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. 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

    PRODUCT EVENT SUMMARY: THE CATHETER WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE CATHETER HAD A SPIRAL SLIT. IT WAS NOTED THAT THE CATHETER SHAFT WAS BENT, AND VISUAL SUMMARY ANALYSIS OF THE CATHETER INDICATED DAMAGE AT IMPLANT. THE ANALYST COMMENTED THAT SPIRAL SLITTING STARTED AT THE HANDLE AND OCCURRED THROUGHOUT THE SHAFT (TECHNIQUE ISSUE). THE SHAFT WAS KINKED AT VARIOUS LOCATIONS. BLOOD WAS VISIBLE ON THE SHAFT.

    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 IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THE LEAD DISLODGED WHILE THE CATHETER WAS BEING SLIT. THE PHYSICIAN WAS NOT SATISFIED WITH THE CATHETER AND USED A DIFFERENT TYPE OF CATHETER TO IMPLANT THE SAME LEAD. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470578 ATTAIN COMMAND CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6250S02 0006568594

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR