BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2201928 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11232
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 9, 2011
    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
    TX, 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 AND ANALYZED; ANALYSIS REVEALED ALL CONDUCTORS WERE DISTORTED. THERE WAS DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN IMPLANT ATTEMPT, THE GUIDEWIRE COULD NOT BE PASSED THROUGH THE LEAD AND STOPPED ABOUT 5 CM FROM THE PIN. A STYLET WAS ATTEMPTED TO BE PASSED WITH THE SAME RESULTS. THE LEAD WAS NOT IMPLANTED, NOR INTRODUCED INTO THE PATIENT, RATHER ANOTHER LEAD WAS SUCCESSFULLY USED. 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 73 YR Other