BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2203390 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12334
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    October 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006/S002
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD DISLODGED ONE DAY AFTER IMPLANT RESULTING IN HIGH THRESHOLDS AND DIAPHRAGMIC STIMULATION. IT WAS ALSO NOTED THAT THE PATIENT WAS ADVISED FOR EPICARDIAL LEFT VENTRICULAR LEAD IMPLANTATION DUE TO SMALL CORONARY SINUS BRANCHES BUT THE PATIENT REFUSED. THE DEVICE WAS THEN PROGRAMMED AS A DUAL CHAMBER ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) AS NO FURTHER ACTIONS WILL BE TAKEN. 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 PLUS IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4296 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention