BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3860872 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05280
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 9, 2014
    Report Date
    March 20, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT TRIGGERED DUE TO OVERSENSING AND HIGH OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE. IT WAS ALSO REPORTED THAT THERE WAS FLUCTUATING IMPEDANCE. THE PATIENT IS BEING TREATED WITH RADIATION FOR CANCER, AND IS CONCERNED WITH REVISING THE LEAD AT THIS TIME. THE PATIENT WILL BE MONITORED. 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
    342407 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR D224VRC DEFIBRILLATOR