BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1855231 · Received October 6, 2010

    Report

    Report Number
    2649622-2010-09675
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    July 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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 ANALYSIS FOUND NO ANOMALIES. IT WAS ALSO FOUND THAT THERE WAS BLOOD / BODY FLUID ON ALL CONDUCTORS AT THE ELECTRODE END. THE LEAD WAS STRETCHED. THE FULL LEAD WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD WAS ATTEMPTED TO BE IMPLANTED, BUT COULD NOT BE IMPLANTED DUE TO PATIENT ANATOMY. THE LEAD WAS REMOVED. 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 IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention