BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 13018030 · Received December 16, 2021

    Report

    Report Number
    2649622-2021-24938
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    August 12, 2019
    Report Date
    December 16, 2021
    Manufacturer
    MPRI
    Product Code
    NVY
    UDI-DI
    00643169082267
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: PRODUCT ID: 407652 LEAD, DATE OF IMPLANT (B)(6) 2013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LITTLE MORE THAN TWO YEARS PRIOR THE RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED AN INCIDENT OF T-WAVE OVERSENSING (TWOS) POST-PACE, POST-SENSE. IT WAS FURTHER REPORTED THAT THE RV LEAD HAD A HIGH THRESHOLD MEASUREMENT APPROXIMATELY 3 MONTHS PRIOR. THE 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
    1915915 SPRINT QUATTRO SECURE MRI SURESCAN PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62 00643169082267

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male DTMA1QQ CRT-D, 429888 LEAD,