BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 2951877 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00262
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 7, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. CONCOMITANT MEDICAL PRODUCTS: 5068, IMPLANTABLE PACING LEAD, (B)(6) 2003; 5076, IMPLANTABLE PACING LEAD, (B)(6) 2003; D224TRK, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAS HIGH THRESHOLDS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56689 ATTAIN STARFIX ELECTRODE, PACEMAKER, PERMANENT OJX MPRI 419588C

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR 6949 IMPLANTABLE TACHY LEAD