BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 2791425 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14524
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    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. EVALUATION SUMMARY FOR (B)(4): PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE. THE WEEKLY PACING LEAD MEASUREMENT LOG DATA SHOWS A GRADUAL INCREASE FOR THE MINIMUM AND MAXIMUM RIGHT VENTRICULAR PACING IMPEDANCE MEASUREMENTS FROM 400 TO 584 OHMS BETWEEN (B)(4) 2011 AND (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD IMPEDANCE MEASUREMENTS HAVE SLOWLY INCREASED. 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
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD