BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 2123972 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08209
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    February 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. EVALUATION SUMMARY (B)(4) UPON ANALYSIS IT WAS REPORTED THAT THERE WERE NO ANOMALIES FOUND, THERE WAS BLOOD IN/ON THE OUTER TUBING OVERLAY, AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE FULL LEAD WAS RETURNED FOR ANALYSIS. EVALUATION SUMMARY (B)(4): UPON ANALYSIS IT WAS REPORTED THAT THERE WERE NO ANOMALIES FOUND, AND THE PROXIMAL CONDUCTOR WAS DISTORTED. IT WAS APPARENT THAT DAMAGE OCCURED DURING IMPLANT. THE FULL LEAD WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT OF A LEFT VENTRICULAR LEAD, THERE WERE POSITIONING DIFFICULTIES. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE SAME PROCEDURE, THERE WERE HIGH THRESHOLDS ON THE DEFIBRILLATION LEAD. A PACE/SENSE LEAD WAS IMPLANTED IN THE RIGHT VENTRICLE, BUT IT ALSO HAD HIGH THRESHOLDS. THE LEAD WAS EXPLANTED. THE DEFIBRILLATION 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 76 YR Other