BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3071687 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05227
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 2007 (B)(6); 4076 IMPLANTABLE PACING LEAD 2006 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH, CHEST PRESSURE AND WAS ANXIOUS WHEN THEY HAD TWO EPISODES OF WHAT APPEARS TO BE VENTRICULAR (VT) THAT WERE NOT TREATED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE FIRST EPISODE WAS CLASSIFIED AS A VT MONITOR RHYTHM AND THE SECOND EPISODE WAS CLASSIFIED AS SINUS TACHYCARDIA (ST). THE R-WAVE AMPLITUDE ON THE VENTRICULAR LEAD WAS NOTED TO BE SMALL. THE LEAD AND DEVICE REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171829 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR