BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1991966 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00167
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 17, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE RIGHT VENTRICULAR LEAD DISLODGED WHILE PLACING THE LEFT VENTRICULAR LEAD. THE RIGHT VENTRICULAR LEAD WAS REPOSITIONED AND REMAINS IMPLANTED. THE LEFT VENTRICULAR LEAD TRIED FOR A SECOND ATTEMPT. WHILE TRYING TO SLIT THE CATHETER, IT STUCK TO THE LEAD AND THE LEAD WAS PULLED OUT OF THE VESSEL. A THIRD ATTEMPT WAS MADE TO PLACE THE LEFT VENTRICULAR LEAD BUT IT WAS UNSUCCESSFUL. THE LEAD WAS REMOVED AND NOT REPLACED. NO PATIENT COMPLICATIONS WERE 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, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB