BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2123119 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07920
    Event Type
    Injury
    Date Received
    June 14, 2011
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE PROXIMAL CONDUCTOR WAS CUT. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THE DEFIBRILLATION COIL WAS DISTORTED, SEVERAL CONDUCTORS WERE DISTORTED, THE DISTAL CONDUCTOR WAS STRETCHED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING WAS KINKED/BUCKLED, THE OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER TUBING HAD AN ENVIRONMENTAL STRESS CRACKING BREACH/BREACH (NON-ELECTRICAL), THE INNER TUBING WAS TORN, THE OUTER INSULATION WAS TORN, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATOR COIL, THE HELIX/LOBE WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THE LEAD WAS STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    THE LEAD WAS PROPHYLACTICALLY REMOVED AND REPLACED. THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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 FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6931 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 7297 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD