BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2203309 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11684
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 10, 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
    CA
    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, ANALYZED AND THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED). IT WAS NOTED THAT ALL CONDUCTORS WERE DISTORTED, THE DISTAL CONDUCTOR HAD BLOOD/FLUID WHICH CREATED AN OBSTRUCTION, A STYLET WAS STUCK IN LEAD DISTAL COIL, THE LEAD APPEARED DAMAGED AT IMPLANT AND THE LEAD WAS STRETCHED. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND ALL CONDUCTORS WERE DISTORTED. IT WAS NOTED THAT THE LEAD APPEARED DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AT FIRST THE IMPLANTER DECIDED TO USE AN ANGIOPLASTY WIRE FOR THE PLACEMENT OF THE LEFT VENTRICULAR LEAD. AFTER PROLONGED DELAY, THE IMPLANTER REALIZED THAT THE ANGIOPLASTY WIRE WAS SHOWING SIGNIFICANT RESISTANCE TO RETRACT OR ADVANCE. THE LEAD WAS REMOVED AND REPLACED AS THE WIRE WAS FUSED TO THE INTERIOR OF THE LEAD LUMEN. THE SECOND LEAD AND ANGIOPLASTY WIRE EXHIBITED A SIMILAR RESPONSE. A THIRD LEAD WAS USED WITH A HYBRID WIRE WITHOUT ANY ISSUE. NO PATIENT COMPLICATIONS WERE 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 Other