BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2131385 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10485
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND AND ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED.)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THE LEAD WAS POSITIONED WITH APPROPRIATE CAPTURE THRESHOLDS. HOWEVER, THE THRESHOLD BECAME ELEVATED AFTER HOOKING UP TO THE DEVICE IN ALL CONFIGURATIONS. THE LV LEAD WAS AGAIN REPOSITIONED, BUT PULLED BACK AFTER SLITTING; THEREFORE THE LEAD WAS ABANDONED AND A NEW LEAD IMPLANTED DUE TO THE PATIENT'S ANATOMY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE LEFT VENTRICULAR 9LV) LEAD, THE LEAD WAS POSITIONED WITH APPROPRIATE CAPTURE THRESHOLDS. HOWEVER, THE THRESHOLD BECAME ELEVATED AFTER HOOKING UP TO THE DEVICE IN ALL CONFIGURATIONS. THE LV LEAD WAS AGAIN REPOSITIONED, BUT PULLED BACK AFTER SLITTING; THEREFORE, THE LEAD WAS ABANDONED AND A NEW LEAD IMPLANTED DUE TO THE PATIENT'S ANATOMY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other 6943 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6943 IMPLANTABLE TACHY LEAD