BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2203704 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12595
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. EVALUATION SUMMARY : (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED A DIAGNOSTICS PROBLEM. THERE WERE 2 PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2011. PROGRAMMER ALERT EVENT DATA SHOWS 2 PATIENT ALERTS FOR "SVC DEFIB LEAD IMPEDANCE NOT TAKEN" ON (B)(6) 2011 02:15:03 AND (B)(6) 2011 02:15:03.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SUPERIOR VENA CAVA COIL IMPEDANCE COULD NOT BE MEASURED ON THE VENTRICULAR LEAD AND THIS TRIPPED THE PATIENT ALERT. DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 78 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD