BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1991980 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02666
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    November 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 WHERE IT WAS DISCOVERED THAT THE HELIX WAS DISENGAGED FROM HELICAL CHANNEL. THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR NEAR THE TIP, IN/ON THE HELIX MECHANISM AND THE SLEEVEHEAD. THE INNER TUBING WAS KINKED/BUCKLED. THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE A PROBLEM OCCURRED WITH THE HELIX MECHANISM OF THE LEAD. A NEW LEAD WAS USED. 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 LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other