BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1923041 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13200
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 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
    PA, 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. THERE WAS BLOOD/BODY FLUID ON THE CONDUCTORS (NOT OBSTRUCTED) NEAR THE ELECTRODE END OF THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS NOT SUCCESSFULLY IMPLANTED DUE TO PATIENT ANATOMY AND WAS DIFFICULT TO POSITION. THE LEAD WAS NOT USED. 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 87 YR Other