BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2811293 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16108
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    June 26, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006/S002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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 AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON ALL CONDUCTORS, INCLUDING THE DISTAL CONDUCTOR (NOT OBSTRUCTED), AND ALL CONDUCTORS WERE STRETCHED. THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT. THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH THE COILS STRETCHED, HOWEVER, THE GUIDE WIRE TEST WAS PERFORMED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, PROBLEMS WERE ENCOUNTERED WHEN ATTEMPTING TO INSERT THE STYLET AND THE GUIDEWIRE INTO THE LEAD. THE LEAD WAS NOT USED AND ANOTHER 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 PLUS IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4296

    Patients

    Seq Age Sex Outcome Treatment
    1 Other