BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2203701 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11891
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 27, 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
    NC, 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 FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE GUIDEWIRE WAS STUCK IN THE LEAD. IT WAS NOTED THAT ALL CONDUCTORS WERE STRETCHED, THE OUTER INSULATION WAS BREACHED CUT, THE LEAD APPEARED DAMAGED AT IMPLANT AND THE LEAD WAS STRETCHED. THE ANALYST COMMENTED THAT IT WAS APPARENT THAT WHEN ATTEMPTING TO PULL BACK THE GUIDEWIRE, ITS COATING BECAME ENSNARED WITH THE DISTAL CONDUCTOR. THIS CAUSED A DISTORTION OF THE FILARS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL IMPLANT, THE GUIDE WIRE GOT STUCK IN THE LEFT VENTRICULAR (LV) LEAD AND COULD NOT BE REMOVED. THE LV LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. 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 70 YR Other