BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1925336 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13804
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 1, 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
    OH, 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 NO ANOMALIES WERE FOUND. THE DEFIBRILLATION CONDUCTOR WAS DISTORTED SUSPECTED TO BE DUE TO THE IMPLANT PROCEDURE. THE DISTAL CONDUCTOR HAS BLOOD/BODY FLUID IN/ON IT AT VARIOUS LOCATIONS THROUGHOUT THE LEAD. THE OUTER INSULATION AND OVERLAY TUBING WAS BREACHED DUE TO CUT. THE HELIX WAS DISTORTED/BENT. THERE WAS BLOOD IN/ON THE HELIX AND SLEEVEHEAD. THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE RIGHT VENTRICULAR LEAD WAS NOT SENSING PROPERLY AT ITS INITIAL LOCATION. THE LEAD WAS REPOSITIONED, HOWEVER THE HELIX COULD NOT BE EXTENDED AFTER MANY TURNS. DURING ONE ATTEMPT, THE HELIX POPPED OUT INTO ITS EXTENDED POSITION, HOWEVER THE LEAD IMPEDANCE WAS HIGH AND CAPTURE COULD NOT BE OBTAINED. THE LEAD WAS REMOVED AND REPLACED. 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 61 YR Other