BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3991665 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08009
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCTS: (B)(4) ICD 2014 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO NOISE, A NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODE AND HIGH IMPEDANCE ON THE LOW VOLTAGE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD. A FRACTURE WAS CONFIRMED. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467686 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694865

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R 5554-45 LEAD