BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1013392 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00954
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    December 7, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: PROXIMAL CONDUCTOR FRACTURED; FULL LEAD RETURNED AND ANALYZED

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA 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: PROXIMAL CONDUCTOR FRACTURED; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS REPLACED DUE TO CONCERN ABOUT A 'TREND THEY WERE SEEING IN THE LEAD AND DID NOT WANT HIM TO GET SHOCKED INAPPROPRIATELY'. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT'S ATTORNEY. ALLEGED THAT THE PATIENT HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES, INCLUDING INAPPROPRIATE THERAPIES, SEVERE EMOTIONAL DISTRESS, AND ECONOMIC AND CONSEQUENTIAL DAMAGES DUE TO THE 'DEFECTIVE' AND FRACTURED LEAD.

    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 22 YR Required Intervention 5076 IMPLANTABLE PACING LEAD