BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STABILITY

    MDR report key: 4161591 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02659
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 8, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. 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. 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: NOVEL ACTIVE FIXATION MECHANISM PERMITS PRECISE PLACEMENT OF A LEFT VENTRICULAR LEAD: EARLY RESULTS FROM A MULTICENTER CLINICAL STUDY. HEART RHYTHM. 2014;11(7):1150-1155. AN EMAIL WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF YET. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. DURING THE IMPLANTATION OF THE LEAD, THE LEAD WAS SUCCESSFULLY IMPLANTED HOWEVER THE SITE WAS CONSIDERED UNACCEPTABLE DUE TO PHRENIC NERVE STIMULATION DESPITE PROGRAMMING. THERE WAS ALSO A REPORT OF HIGH PACING THRESHOLDS. THE LEADS WERE REPLACED. FURTHER NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641857 ATTAIN STABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC, INC. 20066

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention