BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 8621400 · Received May 17, 2019

    Report

    Report Number
    2649622-2019-08463
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 17, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00643169356566
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED APPROXIMATELY TWO MONTHS POST IMPLANT THAT A SINGLE T-WAVE OVERSENSING (TWOS) EVENT WAS OBSERVED ON PRESENTING RHYTHM STRIP AS WELL AS A NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODE ON THE RIGHT VENTRICULAR (RV) LEAD. THE 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
    414453 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62 00643169356566

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR DTMA1QQ CRTD, 459888 LEAD, 6725 ADAPTOR