BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3992471 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09844
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO, OPERATIONS CO., VILLALBA
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 AFTER THE DEVICE CHANGE OUT IT WAS NOTED THAT THE SUPERIOR VENA CAVA (SVC) MEASURED "NONE". CALLER STATED THAT THERE WAS AN ELECTROGRAM (EGM) TRACING ON THE SVC-CAN EGM. THE REPRESENATIVE WAS INSTRUCTED TO DISCONNECT THE RIGHT VENTRICULAR (RV) LEAD FROM THE DEVICE AND TEST USING THE ANALYZER. THE POCKET HAD ALREADY BEEN CLOSED; THUS, THE POCKET WILL BE RE-OPENED. IT WAS SUSPECTED THAT THE SVC PIN WAS NOT FULLY INSERTED OR THAT THERE WAS AN SVC COIL FRACTURE. THE STATUS OF THE LEAD IS UNKNOW. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468179 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, OPERATIONS CO., VILLALBA 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention