BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3051018 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04779
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    November 16, 2012
    Report Date
    January 24, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THERE WAS OVERSENSING WITH VENTRICULAR NON-SUSTAINED TACHYCARDIA EQUAL TO 190 MS ON (B)(4)-2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ONE EPISODE OF FAST VENTRICULAR NON-SUSTAINED TACHYCARDIA AND A SHORT INTERVAL COUNT (SIC) OF TWO. IT WAS ALSO NOTED THAT THERE WAS A MEDICATION CHANGE AROUND THIS TIME AND FURTHER MONITORING AND TESTING WERE RECOMMENDED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149437 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR 7232CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR