BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2053493 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05912
    Event Type
    Injury
    Date Received
    April 13, 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
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE LEFT VENTRICULAR (LV) LEAD WARNING SOUNDED DUE TO VARIABLE LEAD IMPEDANCES AT THE PATIENT'S FIRST OFFICE CHECK SINCE THE LEAD REVISION. THE LEAD HAD BEEN REVISED A FEW DAYS PRIOR TO THE LEAD WARNING DUE TO A LEAD DISLODGEMENT. THERE WERE ALSO NOTED UNACCEPTABLE THRESHOLDS. THE CLINICAN CALLED TO DISCUSS AND TEST AVAILABLE LV LEAD CONFIGURATIONS. THE LEAD REMAINS IN USE. 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 PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 8042 IMPLANTABLE PULSE GENERATOR