BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 2791471 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14836
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. IT WAS REPORTED THAT THE DEVICE MET EXPECTED LONGEVITY WITH NORMAL DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT MEET THE EXPECTED LONGEVITY. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THE THRESHOLD MEASUREMENTS ON THE LEFT VENTRICULAR LEAD WERE HIGH. THE LEAD WAS REPROGRAMMED AND 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 OJX MEDTRONIC PUERTO RICO, INC. 4195

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD