BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 3045185 · Received April 9, 2013

    Report

    Report Number
    2649622-2013-02768
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. IMPEDANCE/LOW IMPEDANCE: 1 - PATIENT ALERT FOR OOT SUBTHRESHOLD LEAD IMPEDANCE (B)(6) 2012 03:00:17. PROGRAMMER DATA SHOWS 1-ALERT EVENT "LVTIP TO RVCOIL LEAD IMPEDANCE 171 OHMS" ON (B)(6) 2012 03:00:17. CONCOMITANT PRODUCTS: 6947 IMPLANTABLE TACHY LEAD - (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF 'PULSING' WITH EACH DEVICE PACE, AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW IMP EDANCES. THE LV LEAD PACING WAS PROGRAMMED OFF, AND THE PULSING RESOLVED. THE LEAD REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145021 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention D314TRG IMPLANTABLE DEFIBRILLATOR