BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2610678 · Received June 11, 2012

    Report

    Report Number
    2649622-2012-07420
    Event Type
    Injury
    Date Received
    June 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S030
    Removal / Correction Number
    Z-0069-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4) PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND REVEALED THAT THERE WAS HIGH RESISTANCE/IMPEDANCE, 2 - PATIENT ALERTS FOR RIGHT VENTRICULAR PACE LEAD Z ON (B)(6) 2011 03:00:03 AND (B)(6) 2011 03:00:03. THE WEEKLY PACE MEASUREMENT LOG DATA SHOWS A GRADUAL INCREASE FOR MINIMUM AND MAXIMUM VENTRICULAR PACE = 504 TO 1424 OHMS PEAK BETWEEN (B)(6) 2011 AND (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT ALERT AND THE RIGHT VENTRICULAR (RV) LEAD HAD SLOWLY, INCREASING, HIGH IMPEDANCE AND HIGH THRESHOLD. THE RV 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6948

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB