BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 4829911 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01851
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 1, 2015
    Report Date
    April 6, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: ¿REMOVAL OF ACTIVE-FIXATION CORONARY SINUS LEADS USING A MECHANICAL ROTATION EXTRACTION DEVICE. PACE 2015; 38:302-305." (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS RECEIVED WHICH CONTAINED INFORMATION REGARDING THIS PATIENT'S ACTIVE FIXATION CORONARY SINUS LEAD. THE ARTICLE NOTED THE INDICATION FOR LEAD EXTRACTION WAS LEAD INFECTION. SIGNIFICANT TISSUE GROWTH BETWEEN THE FIXATION LOBES WAS OBSERVED ON THE LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374614 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC, INC. 4195

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R