BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 4160162 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12005
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION NOTED BUT RETURNED PRODUCT INVESTIGATION FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. THE DEVICE IS NO LONGER INCLUDED AS PART OF THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE LOW VOLTAGE PORTION AND RV COIL PORTION OF THE RV LEAD WERE CAPPED AND THE SUPERIOR VENA CAVA (SVC) COIL REMAINS IN USE. A NEW SINGLE COIL HIGH VOLTAGE LEAD WAS ADDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638922 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R