BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 2951420 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00105
    Event Type
    Injury
    Date Received
    February 9, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    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 PRODUCTS: 6947, IMPLANTABLE TACHY LEAD, (B)(6) 2010; D224TRK, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR,  (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE PHYSICIAN IS PLANNING TO REPOSITION THE LV LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55649 ATTAIN STARFIX ELECTRODE, PACEMAKER, PERMANENT OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD