BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4831653 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05407
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 20, 2015
    Report Date
    March 20, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT MEDICAL PRODUCTS: 5568-53 LEAD, IMPLANTED: (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT VIA REMOTE MONITOR REPORTS, FAR FIELD R-WAVE (FFRW) WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE LEAD REMAINS IN USE. T-WAVE OVERSENSING (TWOS) WAS ALSO REPORTED ON THE RIGHT VENTRICULAR (RV) LEAD. ACCORDING TO MANUFACTURER RECORDS, TWO RV LEADS WERE IN USE. ONE RV LEAD HAS SINCE BEEN INACTIVATED DUE TO UNSPECIFIED REASONS. THE PATIENT ALSO COMMENTED ON HAVING ISSUES WITH RATE RESPONSE AND A FAST HEART RATE WITH CERTAIN ACTIVITIES. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS SINCE BEEN EXPLANTED AND REPLACED FOR UNRELATED REASONS. FURTHER CLARIFYING INFORMATION WAS UNAVAILABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374265 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR D224DRG ICD, 694765 LEAD