BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 4833879 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06876
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    December 23, 2014
    Report Date
    April 13, 2015
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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 DURING THE IMPLANT PROCEDURE OF THE LEFT VENTRICULAR (LV) LEAD, DIAPHRAGMATIC MUSCLE STIMULATION WAS ENCOUNTERED. THE LV LEAD WAS REMOVED AND REPLACED ANOTHER LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376015 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 4195

    Patients

    Seq Age Sex Outcome Treatment
    1