BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 3153067 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05806
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    January 22, 2013
    Report Date
    December 27, 2023
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT IT WAS DIFFICULT TO GET CONSISTENT MEASUREMENTS AND MATCHES FOR THE R-WAVES ON THE RV (RIGHT VENTRICULAR) LEAD. A CHEST X-RAY WAS DONE AND SHOWED THAT THE RV LEAD HAD MOVED AS IT HAD DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT IS ENROLLED IN THE (B)(4) STUDY (SLS) NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255128 SPRINT QUATTRO SECURE MRI SURESCAN PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R