BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 2130949 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10316
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 ANALYZED WITH NO ANOMALIES FOUND. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON THE DISTAL CONDUCTOR AND OUTER TUBING OVERLAY. THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLD AND NO CAPTURE. THE TINE WOULD NOT HOLD THE LEAD IN POSITION. THE LEAD WAS REMOVED AND REPLACED BY A NEW LEAD. NO PATIENT COMPLICATIONS WERE 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 66 YR Hospitalization| O| R D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD