BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 1792329 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07073
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    May 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Report Source
    Manufacturer report
    Reporter Location
    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A GRADUAL INCREASE IN THE LEAD IMPEDANCE ON THE PACE/SENSE PORTION OF THE HIGH VOLTAGE LEAD, THAT THE IMPEDANCE IS NOW >1600 OHMS, AND THAT CAPTURE THRESHOLD HAS DOUBLED. IT WAS NOTED THERE WAS NO ABRUPT CHANGE IN LEAD IMPEDANCE. THE LEAD IS STILL 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
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD