BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2122501 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07865
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL. THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE HELIX/LOBE MECHANISM (SLEEVE HEAD). THERE WAS A TIP SEAL OBSERVATION.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER AFTER THE HELIX WOULD NOT EXTEND OR RETRACT DURING AN IMPLANT ATTEMPT. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. 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 LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other