BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 2051745 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05661
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD INTERMITTENT EXIT BLOCK AND INCREASED THRESHOLDS. THE LEAD OUTPUT WAS ADJUSTED AND THE LEAD REMAINS 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
    1 ATTAIN STARFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4195 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD