BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1922173 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12784
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE 6949 DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ANALYSIS OF THE DEVICES ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE 6949 DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) A PORTION OF THE LEAD WAS RETURNED IN SEGMENTS WHERE NO ANOMALIES WERE FOUND. THE DEFIBRILLATION CONDUCTOR WAS DISTORTED AND FRACTURED WHICH IS SUSPECTED TO BE DUE TO THE EXPLANT PROCEDURE. THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS, THE SLEEVEHEAD MECHANISM AND ON THE OUTER TUBING AT VARIOUS LOCATIONS THOUGHOUT THE LEAD. THE OUTER TUBING WAS KINKED/BUCKLED AND MELTED. THERE WAS DEPRESSION ON THE OUTER INSULATION NEAR THE CONNECTOR. (B)(4) THE FULL LEAD WAS RETURNED WHERE NO ANOMALIES WERE FOUND. THERE WAS BLOOD/BODY FLUID IN/ON THE HELIX MECHANISM AND SLEEVEHEAD. THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN SURGERY FOR A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT. THE SURGEON NOTED THAT THE 6949 RV LEAD HAD PERFORATED THE SEPTAL WALL AND WAS IN THE LEFT VENTRICLE. THE SURGEON CUT THE TIP OF THIS LEAD OFF, SUTURED THE SEPTUM, AND HAD THE DEVICE PROGRAMMED OFF. ABOUT A WEEK LATER DURING ANOTHER PROCEDURE, THE 6949 LEAD WAS REMOVED. A 6935 LEAD WAS ATTEMPTED TO BE PLACED BUT WAS ABANDONED DUE TO A STERILITY ISSUE WHEN THE SURGEON'S GLOVE BROKE. A DIFFERENT 6935 LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD