BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2203261 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11675
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 17, 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
    NY, 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 NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN NOTICED THE COATING OF THE GUIDE WIRE COMING OFF AND GETTING LODGED IN THE LEFT VENTRICULAR LEAD. THE PHYSICIAN WAS UNABLE TO PASS ANOTHER WIRE THROUGH THE LEAD. THE LEAD WAS NOT IMPLANTED. A NEW LEAD WAS GIVEN AND THE CASE WAS COMPLETED. 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 81 YR Other