BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 1864692 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10979
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    August 2, 2010
    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
    KY, 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) FULL LEAD RETURNED AND ANALYZED. NO ANOMALIES FOUND. BLOOD ON THE DISTAL CONDUCTOR, ON THE OUTER TUBING OVERLAY, AND IN/ON THE HELIX MECHANISM. THE HELIX WAS FOUND DISTORTED/BENT; LEAD DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS ATTEMPTED TO BE IMPLANTED HOWEVER, BECAUSE THE VEINS WERE VERY SMALL AND THE THRESHOLDS WERE UNSTABLE, THE LEAD WAS UNABLE TO BE POSITIONED. THE LEAD WAS NOT IMPLANTED. THE LEAD WAS REPLACED. 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 75 YR Required Intervention