BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2131612 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10665
    Event Type
    Injury
    Date Received
    June 16, 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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS ORIGINALLY REMOVED DUE TO INFECTION. THIS EVENT WAS REPORTED ON AN ALTERNATIVE SUMMARY REPORT THAT WAS SUBMITTED (B)(6) 2008. THE LEAD WAS RETURNED TO THE MANUFACTURER (B)(6) 2011 AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. EVALUATION SUMMARY: (B)(4): THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND THE DEFIBRILLATOR CONDUCTOR FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION WAS MELTED, OUTER TUBING OVERLAY WITH COSMETIC ENVIRONMENTAL STRESS CRACK AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. 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.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER, WAS ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO 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 38 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD