BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1992506 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02888
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 30, 2010
    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
    MO, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT OF THE LEFT VENTRICULAR LEAD THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. IT WAS REPOSITION BUT CONTINUED TO HAVE THE SAME EFFECT. THE LEAD WAS REMOVED AND REPLACED SUCCESSFULLY WITH A NEW LEAD. THE PATIENT DID HAVE COMPLICATIONS THAT OCCURRED AFTER THE SUCCESSFUL IMPLANT OF A NEW DEVICE AND LEAD THAT WERE A RESULT OF ANESTHESIA AND NOT RELATED TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS LEAD NOT BEING SUCCESSFULLY IMPLANTED.

    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 62 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6931 IMPLANTABLE TACHY LEAD