BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1875148 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11638
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    March 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. THE EVENT OCCURRED OUTSIDE THE US. 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) CONDUCTOR WEAR - PROXIMAL CONDUCTOR, DEFIB CONDUCTOR DISTORTED, SEVERAL CONDUCTORS DISTORTED, OUTER TUBING KINKED/BUCKLED, INNER TUBING TORN, EXPOSED DEFIB COIL WITH WHITE SUBSTANCE, AND BLOOD WAS NOTED ON DISTAL CONDUCTOR (NOT OBSTRUCTED), SEVERAL CONDUCTORS (NOT OBSTRUCTED), HELIX MECHANISM, AND OUTER TUBING OVERLAY; DISTAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT FOLLOW UP ELECTRICAL "NOISE" WAS NOTED ON THE ELELCTROGRAM TELEMETERED FROM THE LEAD. THE LEAD WAS REMOVED, REPLACED AND RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE LEAD WAS 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. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention