BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3862549 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06856
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 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. PRODUCTS: 5076 LEAD IMPLANTED: 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RECENT DEVICE REPLACEMENT PROCEDURE AND SUBSEQUENTLY AN ALERT WAS TRIGGERED FOR HIGH LEAD IMPEDANCE IN THE HIGH VOLTAGE COILS. A REAL TIME MEASUREMENT REVEALED IMPEDANCE VALUES WITHIN THE EXPECTED RANGE AND IT WAS INDICATED AS AN INTERMITTENT ISSUE. THE RIGHT VENTRICULAR (RV) 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
    340970 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR (B)(4) ICD