BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 2952910 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00748
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) IN LESS THAN TWO YEARS AND THE DEVICE LONGEVITY WAS LESS THANEXPECTED. ALSO, THE LEFT VENTRICULAR (LV) LEAD THRESHOLD WAS VERY HIGH AND NEEDED TO HAVE A PROGRAMMED VALUE OF 5-6 VOLTS AT 1.5 MILLISECONDS. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LV LEAD IS STILL 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
    57271 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR