BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3151968 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05582
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE PARTIAL LEAD WAS RETURNED IN SEGMENTS. THE PRIMARY ANALYSIS REVEALED NO ANOMALIES. IT WAS ALSO NOTED THAT THE VISUAL ANALYSIS REVEALED THE LEAD HAD APPARENT EXPLANT DAMAGE. PRODUCT ID: 7232CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTED: 2005 (B)(6), EXPLANTED: 2013 (B)(6); 6931 IMPLANTABLE TACHY IMPLANTABLE TACHY LEAD IMPLANTED: 2005 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD T-WAVE OVERSENSING (TWOS). THE RV LEAD WAS EXPLANTED 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
    252602 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization| R