BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 2953368 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01087
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 31, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BY THE ONE DAY POST-OPERATIVE CHECK IT WAS DISCOVERED THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. THE LV LEAD HAD NO SENSING AND NO CAPTURE. IT WAS NOTED THAT THE IMPLANTING PHYSICIAN THOUGHT THE ORIGINAL TARGET VEIN WAS QUITE LARGE AND ONLY THE IMPLANTED LEAD MODEL HAD A CHANCE OF STAYING IN PLACE. THE PATIENT WAS HOSPITALIZED UNTIL THE LV LEAD WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL LV LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57516 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R 6947M IMPLANTABLE TACHY LEAD