BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811438 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16843
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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). THE FULL LEAD WAS RETURNED, ANALYZED AND THE DEFIBRILLATION CONDUCTOR WAS DISTORTED. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, THE LEAD APPEARED DAMAGED AT IMPLANT AND THE STYLET WAS BENT. VISUAL ANALYSIS NOTED THAT THE SUPERIOR VENA CAVA EXPOSED COIL IS SLIGHTLY DISTORTED AT 36.5 CM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE LEAD COULD NOT BE NAVIGATED INTO A SATISFACTORY POSITION IN THE RIGHT VENTRICLE DUE TO AN EXTREMELY TORTUOUS SUBCLAVIAN VEIN/SUPERIOR VENA CAVA. THE LEAD WAS INSERTED INTO AND REMOVED FROM AN INTRODUCER MULTIPLE TIMES, AND ANOTHER LEAD WAS USED AFTER POTENTIAL COIL DAMAGE WAS NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD NVY MEDTRONIC PUERTO RICO, INC. 6947M

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other