BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1990545 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02059
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 9, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID ON IT (NOT OBSTRUCTED). THE INNER TUBING WAS KINKED/BUCKLED. THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD. THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION. THE LEAD WAS RETURNED WITH A BIG AMOUNT OF DRIED BLOOD IN A SLEEVEHEAD. THE HELIX EXTENDS AND RETRACTS WITHIN PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT THE HELIX OF THE LEAD INITIALLY EXTENDED AND RETRACTED WITHOUT PROBLEM BUT WHEN THE LEAD NEEDED TO BE REPOSITIONED THE LEAD RETRACTED BUT WOULD NO LONGER EXTEND. THE LEAD WAS EXTRACTED AND A DIFFERENT LEAD WAS SUCCESSFULLY 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 LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other