BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 1992477 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00187
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. REFERENCED ARTICLE: "A MODIFIED TRANSVENOUS SINGLE MECHANICAL DILATATION TECHNIQUE TO REMOVE A CHRONICALLY IMPLANTED ACTIVE-FIXATION CORONARY SINUS PACING LEAD." PACING AND CLINICAL ELECTROPHYSIOLOGY. 2010; P1-4.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THESE LEADS. IT WAS REPORTED THAT THESE LEADS NEEDED TO BE EXTRACTED DUE TO LOCAL POCKET INFECTION DUE TO PERSISTENT POSITIVE BLOOD CULTURE (STAPHYLOCOCCUS AUREUS). THERE WAS DIFFICULTY EXTRACTING THE ACTIVE FIXATION LEAD AND IT REQUIRED LONG AND CHALLENGING MECHANICAL DILATATION UP TO DISTAL CS. THE LEAD POSTEXTRACTION EXAMINATION SHOWED THE EXPANDED AND BLOCKED LOBES WITH THE PUSH TUBING FRACTURE AROUND THE LEAD BODY. 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, INC. 4195 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R IMPLANTABLE PACEMAKER/CARDIO/DEFIB