BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1991339 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02359
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 22, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT DEVICE CHANGEOUT PROCEDURE THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE ON THE HVB COIL AND NO IMPEDANCE ON THE SVC COIL. THE LEAD WAS DISCONNECTED, REINSERTED AND THEN THE HVB COIL TESTED NORMAL BUT THE SVC COIL STILL HAD NO IMPEDANCE. THAT SVC COIL WAS PROGRAMMED OFF. THE LEAD REMAINS IN USE AND 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 1688TC COMPETITIVE IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB