BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 3990046 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08858
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD COULD NOT BE FIXED IN THE TARGET POSITION. THE LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465179 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR