BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3153663 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06156
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WAS GUIDEWIRE COATING ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THE DISTAL CONDUCTOR OF THE LEAD WAS OBSTRUCTED DUE TO A STYLET/GUIDEWIRE STUCK IN THE LUMEN. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST COMMENTED, COMPETITOR GUIDEWIRE IS STUCK THROUGHOUT THE LENGTH OF THE LEAD AND CANNOT BE REMOVED. SIGNIFICANT DAMAGE TO THE LEAD HAS OCCURRED DUE TO THE GUIDEWIRE'S COATING BECOMING ENSNARED IN THE LEAD. THE USE OF COMPETITOR GUIDEWIRES IS NOT RECOMMENDED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, AFTER THE ATRIAL LEAD WAS IMPLANTED, THE PHYSICIAN NOTED A SMALL CRIMP IN THE CONDUCTOR COIL TOWARDS THE BACK OF LEAD. ALL ELECTRICAL MEASUREMENTS WERE STABLE BUT THE VISIBLE CRIMP IN THE COIL WAS CONCERNING AND THE PHYSICIAN DECIDED TO REMOVE THE LEAD AND IMPLANT A NEW ONE. IT WAS ALSO REPORTED DURING THE SAME IMPLANT ATTEMPT, WHEN THE GUIDEWIRE WAS BEING REMOVED FROM THE LEFT VENTRICULAR (LV) LEAD IT STUCK IN THE LEAD. THE LEAD CONNECTOR SEPARATED FROM THE LEAD BODY INSULATION AND STARTED TO UNRAVEL THE CONDUCTOR COIL. A DIFFERENT LV 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
    256453 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429678

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR