BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1992436 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02843
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 2, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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. THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS AT VARIOUS LOCATIONS THROUGHOUT THE LEAD AND IN/ON THE SLEEVEHEAD AND IN/ON THE HELIX. THE INNER TUBING WAS KINKED/BUCKLED AND CUT. THE OUTER INSULATION WAS BREACHED CUT. THE OUTER TUBING OVERLAY WAS BREACHED CUT. THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION. THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST NOTED THAT THE HELIX EXTENDS AND RETRACTS WITHIN PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELIX HAD DIFFICULTY EXTENDING AND RETRACTING. THE LEAD WAS EXPLANTED 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 81 YR Other (B)(4) IMPLANTABLE PACING LEAD