BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1991329 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02355
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 2, 2010
    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 : (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS. EVALUATION SUMMARY: (B)(4) : THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THE INITIAL LEAD USED WAS DAMAGED DURING PUSHING AND PULLING OUT OF CATHETERS AND THE TORTUOSITY OF THE PATIENT'S ANATOMY MADE IT DIFFICULT TO MANIPULATE TO MANY PLACES IN THE HEART. IT WAS ALSO DIFFICULT TO ACQUIRE A STABLE POSITION WITH THE SECOND LEAD WHICH PULLED OUT DURING MANIPULATION OF THE CATHETER. THE LEADS WERE ABANDONED DUE TO TORTUOSITY OF THE PATIENT'S ANATOMY. 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 68 YR Other