BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2864776 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17515
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATION CO.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. ADD'L DEVICE: 5554 IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SENSING ABNORMALLY THROUGH THE DEVICE. 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
    1 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATION CO. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 7278 IMPLANTABLE DEFIBRILLATOR