BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2130483 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10172
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    February 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD CAUSED EXTRACARDIAC STIMULATION, SO THE LEAD WAS PROGRAMMED OFF. THE LEAD WAS TURNED BACK ON THE POLARITY WAS CHANGED WHICH RESOLVED THE EXTRACARDIAC STIMULATION AND RESULTED IN AN ELEVATED THRESHOLD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE LEAD DISLODGED AND WAS SUBSEQUENTLY REPOSITIONED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD CAUSED EXTRACARDIAC STIMULATION, SO THE LEAD WAS PROGRAMMED OFF. THE LEAD WAS TURNED BACK ON THE POLARITY WAS CHANGED WHICH RESOLVED THE EXTRACARDIAC STIMULATION AND RESULTED IN AN ELEVATED THRESHOLD. THE LEAD REMAINS 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
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R 1591 COMPETITOR IMPLANTABLE TACHY LEAD| 1591 COMPETITOR IMPLANTABLE TACHY LEAD| 1688TC COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 1688TC COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB