BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3991248 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08226
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: 5554-53 LEAD IMPLANTED: 2011 (B)(6); (B)(4) ICD IMPLANTED: 2011 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED FOR OVERSENSING ON THE RIGHT VENTRICULAR LEAD. THE R-WAVES WERE NOTED TO BE GOOD AND THE IMPEDANCE WAS STABLE. THE LEAD REMAINS IN USE AND CONTINUES TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467845 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR 4396-88 LEAD