BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153571 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06108
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 23, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT T-WAVE OVERSENSING (TWOS) WAS SEEN POST VENTRICULAR PACE. THEREFORE REPROGRAMMING OF VENTRICULAR SENSITIVITY WAS DONE AND THAT CORRECTED THE 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
    257047 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Life Threatening| R (B)(6) IMPLANTABLE PACEMAKER CARDIO/DEFIB