BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3992553 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09828
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0068-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HOURS AFTER A ROUTINE DEVICE CHANGE OUT, OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED. ADDITION ALLY, THERE WAS HIGH IMPEDANCE, HIGH SHORT INTERVAL COUNTS (SIC), AND A LEAD FRACTURE WAS SUSPECTED. AT THE TIME OF THE RV LEAD REPLACEMENT, IT WAS NOTED THAT THE SETSCREW WAS TIGHTENED BUT THE PIN WAS NOT FULLY INSERTED IN THE DEVICE HEADER AND COULD BE PULLED OUT WITHOUT MANIPULATION TO THE SETSCREW. IT WAS ALSO NOTED THAT THERE WAS INSULATION WEAR ON THE LEAD. THE DEVICE REMAINS IN USE AND THE 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
    467115 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693165

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R DVBB1D1 ICD