BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3153204 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05853
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE OF THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: UNKNOWN IMPLANTABLE PACING LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING TACHYARRHYTHMIA WITH A HEART RATE OF 150 BEATS PER MINUTE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOT CAPTURING AT HIGH OUTPUT. DURING THE REVISION, THE LEAD WAS CONNECTED TO THE ANALYZER AND NORMAL VALUES WERE OBSERVED. WHEN THE RV LEAD WAS RECONNECTED TO THE DEVICE, THE RV THRESHOLD MEASUREMENT WAS LOW. AS THE PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF THE DIFFERING THRESHOLD MEASUREMENTS (AND THE DEVICE WAS NEARING THE ELECTIVE REPLACEMENT INDICATOR), THE LEAD WAS CAPPED AND REPLACED AND THE DEVICE WAS EXPLANTED AND REPLACED. ADDITIONALLY, THE PATIENT WAS RESTORED TO NORMAL SINUS RHYTHM WITH A 15 JOULE SHOCK. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256025 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D154ATG IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR