BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1991378 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02369
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) HELIX DISENGAGED FROM HELICAL CHANNEL; THE FULL LEAD WAS RETURNED FOR ANALYSIS. BLOOD/BODY FLUID WAS OBSERVED ON THE HELIX SLEEVE HEAD AND MECHANISM. THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE SCREW GOT STUCK. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE 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 DTB MEDTRONIC PUERTO RICO, INC. 6947M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other