BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 4676682 · Received April 10, 2015

    Report

    Report Number
    2649622-2015-04491
    Event Type
    Injury
    Date Received
    April 10, 2015
    Date of Event
    February 21, 2015
    Report Date
    October 28, 2024
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00613994249890
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 2311-36, DEVICE IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM FOR PRE-SYNCOPE (LIGHT HEADEDNESS AND NAUSEA). WHILE IN THE EMERGENCY ROOM, THEY CAPTURED A PAUSE ON THE ELECTROGRAM. INTERMITTENT LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD WAS ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, IT WAS DETERMINED THAT THE ATRIAL LEAD EXHIBITED HIGH IMPEDANCES WHILE BEING TESTED. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240726 SPRINT QUATTRO SECURE MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765 00613994249890

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R 5076-52 LEAD| 5076-52 LEAD