BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3993147 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09468
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    October 18, 2012
    Report Date
    June 25, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S SPOUSE THAT THE RIGHT VENTRICULAR LEAD AND ATRIAL LEAD WERE BOTH DEFECTIVE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD NOISE. ADDITIONALLY, THE PATIENT REPORTED THAT DURING REPLACEMENT OF THE LEADS, THE SURGEON CUT THE TRICUSPID VALVE WHICH HAD CAUSED LIMITED ABILITY, SHORTNESS OF BREATH, AND QUALITY OF LIFE DIMINISHED. THE PATIENT REPORTED THAT BOTH LEADS WERE REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP CONDUCTED WITH THE FIELD REPRESENTATIVE REVEALED THAT THE RIGHT VENTRICULAR LEAD HAD A RISE OF IMPEDANCE AND THERE WERE NO ISSUES WITH THE ATRIAL LEAD. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467800 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| R 5076-52 LEAD