BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SELECT II

    MDR report key: 3153220 · Received June 8, 2013

    Report

    Report Number
    6000153-2013-00110
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K053431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. PRODUCT EVENT SUMMARY: THE MECHANICAL OPERATION OF THE CATHETER PEELING/SLITTING/SPLITTING SHOWED A SPIRAL SLIT. IT WAS NOTED THAT THE CATHETER WAS DAMAGED, AND A VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. CONCOMITANT PRODUCTS: D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2012, 6935 IMPLANTABLE TACHY LEAD (B)(6) 2012, 5076 IMPLANTABLE PACING LEAD (B)(6) 2012, 4296 IMPLANTABLE PACING LEAD 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED AND WAS NOT CAPTURING. THE LEAD WAS EXPLANTED AND REPLACED. DURING IMPLANT OF A NEW LV LEAD, THE CATHETER BROKE/TORE DURING SLITTING. THE LV LEAD HAD TO BE REMOVED TO REMOVE THE DISTAL PORTION OF THE CATHETER. THE LEAD WAS THEN REINSERTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254979 ATTAIN SELECT II CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 624890D02 624890D02

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR