BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3152029 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05561
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 5, 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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS POST SCHEDULED DEVICE REPLACEMENT, THE RIGHT VENTRICULAR (RV) LEAD SUPERIOR VENA CAVA (SVC) AND RV COILS HAD HIGH IMPEDANCE MEASUREMENTS. THE PHYSICIAN DETERMINED THAT THE RV SET SCREW HAD NOT BEEN SET COMPLETELY DURING THE DEVICE CHANGE-OUT PROCEDURE. 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
    252072 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R D314DRG IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR