BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2130786 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10245
    Event Type
    Injury
    Date Received
    June 16, 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
    MS, 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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE PHYSICIAN WAS NOT ABLE TO TRACK THE LEFT VENTRICULAR (LV) LEAD INTO THE PATIENT'S CHALLENGING VESSEL. THE LV LEAD WAS NOT USED. A DIFFERENT LEAD WAS IMPLANTED. IT WAS ALSO REPORTED THAT THERE WAS HIGH CAPTURE THRESHOLD WITH THE VENTRICLE LEAD. THE VENTRICLE LEAD WAS CAPPED. 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 65 YR Hospitalization| R 4092 IMPLANTABLE PACING LEAD| 4574 IMPLANTABLE PACING LEAD