BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3861195 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07364
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REGULATORY REPORT, REGULATORY REPORT NUMBER 2649622-2014-07364, REPORTED THE 6949 LEAD IMPEDANCE ISSUE DUE TO A LOOSE CONNECTION. THE SAME IMPEDANCE ISSUE WAS REPORTED PREVIOUSLY ON 2012-(B)(6) REGULATORY REPORT NUMBER 2649622-2012-05896, EVENT (B)(4). THE PURPOSE OF THIS SUPPLEMENTAL IS TO REPORT A MERGE. (B)(4).

    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 THE RIGHT VENTRICULAR LEAD HAD AN IMPEDANCE ISSUE DUE TO A LOOSE CONNECTION. THE PHYSICIAN PLANNED TO PLUG THE RV PACE/SENSE PORTION OF THE LEAD INTO THE RIGHT ATRIAL PORT. THE PATIENT HAS CHRONIC ATRIAL FIBRILLATION AND DOESN'T REQUIRE AN ATRIAL LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340191 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R