BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1013477 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00884
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    December 14, 2007
    Report Date
    June 11, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. DETAILED ANALYSIS OF THE DEVICE WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    FURTHER INFORMATION INDICATED THAT THE PATIENT IS PART OF A LAWSUIT ALLEGING THAT THE LEAD IS INHERENTLY DEFECTIVE AND THAT THE PATIENT MAY HAVE SUFFERED DAMAGES AND LOSSES INCLUDING, BUT NOT LIMITED TO: EMOTIONAL DISTRESS, INCLUDING MENTAL DISTRESS, ANGER, DEPRESSION AND ANXIETY. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED, EXHIBITED A HIGH NUMBER OF SHORT V-V INTERVALS, HAD NOISE, AND MEASURED VARYING IMPEDANCE. NO FURTHER 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 MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R