BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN COMMAND

    MDR report key: 4972130 · Received August 5, 2015

    Report

    Report Number
    9612164-2015-01354
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K123153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. CONCOMITANT PRODUCTS: 5076 X 2 LEADS, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLDS AND HAD DISLODGED BACK INTO THE CORONARY SINUS. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE IMPLANT OF THE REPLACEMENT LEAD, THE PHYSICIAN ENCOUNTERED AN ISSUE WITH THE CATHETER WHILE SLITTING. THE PHYSICIAN NOTED THAT THERE WAS WHAT APPEARED TO BE STRETCHED PLASTIC/RUBBER FROM THE BLUE VALVE COMPONENT WITHIN THE HUB OF THE GUIDE CATHETER. THE PHYSICIAN STOPPED SLITTING ONCE THIS WAS NOTICED. THE PHYSICIAN USED A SCALPEL TO CUT AND REMOVE THE PLASTIC/RUBBER FROM THE LEAD AND THEN CONTINUED THE SLITTING. THE NEW LEAD WAS PLACED WITH GOOD THRESHOLD MEASUREMENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517085 ATTAIN COMMAND CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 6250V-EH 0007539903

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR