BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2812662 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16462
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    September 27, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE DEFIB CONDUCTOR WAS DISTORTED. SEVERAL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER TUBING OVERLAY HAD BLOOD/BODY FLUID, WAS MELTED, AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING. THE OUTER INSULATION WAS MELTED. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR [RV] LEAD HAD HIGH THRESHOLD MEASUREMENTS. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR [RV] LEAD HAD HIGH THRESHOLD MEASUREMENTS. THE RV LEAD WAS EXPLANTED AND REPLACED. 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R 7230CX IMPLANTABLE CARDIAC DEFIBRILLATOR| 7230CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB