BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2122086 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07833
    Event Type
    Injury
    Date Received
    June 13, 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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND OUTER INSULATION BREACHED (CLAVICLE RIB CRUSH), THE DISTAL CONDUCTOR WAS DISTORTED, BLOOD/BODY FLUID WAS NOTED ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND ON THE OUTER TUBING OVERLAY, DISTAL CONDUCTOR FRACTURE (OVERSTRESS), OUTER TUBING OVERLAY WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, OUTER INSULATION COSMETIC DEPRESSION, AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED DUE TO A SYSTEM UPGRADE. THE LEAD WAS RETURNED 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. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB