BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2121161 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07793
    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
    NY, 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 PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THERE WAS ELECTRICAL INTERMITTENCY BETWEEN THE PIN AND CAP IN THE CONNECTOR. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DEFIBRILLATION CONDUCTOR (NOT OBSTRUCTED), THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SPIKE IN IMPEDANCE ON THE RV LEAD AND THEN IT RETURNED TO NORMAL LEVELS. THERE IS CONCERN THAT THE LEAD MAY HAVE FRACTURED. THE LEAD WAS 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. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB