BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1991873 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02597
    Event Type
    Injury
    Date Received
    February 15, 2011
    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
    IN, 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, ANALYZED, AND THE DISTAL CONDUCTOR HAD FRACTURED. IT WAS ALSO NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), ON THE OUTER TUBING OVERLAY, ON THE HELIX MECHANISM, AND ON THE SLEEVEHEAD. THE INNER TUBING WAS ALSO KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THERE WAS A TIP SEAL OBSERVATION, AND THERE WAS APPARENT EXPLANT DAMAGE. THE ANALYST NOTED THAT THE HELIX CAN NOT BE EXTENDED OR RETRACTED DUE TO DISTAL CONDUCTOR DISTORTED AND FRACTURED WITHIN THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR DEFIBRILLATION LEAD HELIX HAD PROBLEMS WHEN THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD DUE TO THRESHOLD BEING HIGH/UNSTABLE/UNMEASURABLE. THE LEAD WAS REMOVED AND SUCCESSFULLY 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 75 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB