BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO LEAD

    MDR report key: 3862539 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06854
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    August 4, 2020
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE GRADUAL INCREASES IN THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE AND THRESHOLDS OVER SEVERAL MONTHS. THE LEAD WAS EXHIBITING HIGH LEAD IMPEDANCE AND THE PATIENT WAS REPORTED TO BE VERY ANXIOUS ABOUT THE LEAD AND REQUESTED THE LEAD BE REPLACED. A PLANNED LEAD REPLACEMENT WAS REPORTED, HOWEVER 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
    339510 SPRINT QUATTRO LEAD DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R