BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1854896 · Received October 5, 2010

    Report

    Report Number
    2182208-2010-00649
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 26, 2010
    Report Date
    December 1, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0067-0070-2008
    Report Source
    Manufacturer report
    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREVIOUS FOLLOW-UPS A PACE/SENSE PORTION OF A DEFIBRILLATION LEAD EXHIBITED HIGH THRESHOLDS AND LOW SENSING VALUES. AT THE TIME OF REPLACEMENT OF THE ASSOCIATED IMPLANTABLE DEFIBRILLATOR (ICD), THE PACE/SENSE PORTION OF THE LEAD WAS ABANDONED AND REPLACED WITH A NEW PACE/SENSE LEAD. THE HIGH VOLTAGE PORTION OF THE LEAD 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB