BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2790558 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14427
    Event Type
    Injury
    Date Received
    October 15, 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
    ES
    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. EVALUATION SUMMARY: (B)(4) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS ONE PATIENT ALERT FOR RIGHT VENTRICULAR PACE LEAD IMPEDANCE CHANGE OF 1016 OHMS ON (B)(4) 2012. THE WEEKLY AND DAILY PACE LEAD IMPEDANCE LOG DATA SHOWS AN INCREASE FOR VENTRICULAR PACING OF 464 TO 1016 OHMS PEAK BETWEEN (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICLE IMPEDANCE WAS INCREASED. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED 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 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB