BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2053007 · Received April 13, 2011

    Report

    Report Number
    2182208-2011-00532
    Event Type
    Injury
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND ALL CONDUCTORS WERE FRACTURED. IT WAS NOTED THAT THE ALL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED) AND THE LEAD WAS STRETCHED. THE ANALYST ALSO NOTED THAT A GUIDEWIRE WAS FOUND IN THE ENTIRE LENGTH OF THE LEAD AND WAS BROKEN IN 10 PIECES. THE GUIDEWIRE WAS EASILY REMOVED AND NOT STUCK INSIDE THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD HIGH AND VARYING IMPEDANCE, HISTORICAL HIGH THRESHOLDS, AND NO CAPTURE. AN X-RAY SHOWED A THIN OPAQUE PIECE PROTRUDING FROM THE LEAD, WHICH WAS LATER IDENTIFIED AS A GUIDEWIRE. THE LEAD WAS EXPLANTED AND REPLACED. 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, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R