BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 2203249 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11844
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 THE DISTAL CONDUCTOR AND ON THE OUTER TUBING OVERLAY AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE LEAD COULD NOT BE IMPLANTED DUE TO PATIENT ANATOMY. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. 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 STARFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4195 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIBRILLATOR| 6947 IMPLANTABLE TACHY LEAD