BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 11857051 · Received May 20, 2021

    Report

    Report Number
    2182208-2021-02066
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    July 1, 2020
    Report Date
    May 20, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: TREATMENT OF SYMPTOMATIC BRADYCARDIA DUE TO T-WAVE OVERSENSING WITH IMPLANTATION OF A NEW GENERATOR INCORPORATING DELAYED DECAY AND THRESHOLD START SENSITIZATION ALGORITHMS. HEART RHYTHM CASE REPORTS 2020;6:891¿895. DOI.ORG/10.1016/J.HRCR.2020.06.024. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING T-WAVE OVERSENSING (TWOS). THE ARTICLE REPORTS A PATIENT WHO BEGAN TO EXPERIENCE SEVERELY LIMITING DYSPNEA ON EXERTION, NOTING THEIR HEART RATE WOULD NOT INCREASE WITH EXERCISE DESPITE RATE-RESPONSIVE PROGRAMMING. THEY ALSO REPORTED TWO EPISODES OF SEVERE SYMPTOMATIC BRADYCARDIA. DEVICE ELECTROGRAMS WERE CONSISTENT WITH TWOS. THERE WAS AN INCREASE IN TWOS DURING EXERCISE, WHICH LED TO DOUBLE COUNTING OF THE QRS COMPLEX WITH INHIBITION OF PACING. REPROGRAMMING WAS PERFORMED, BUT THE PATIENT ELECTED TO CHANGE OUT THE DEVICE. THE STATUS/ DISPOSITION OF THE LEAD APPEARS TO BE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753697 SPRINT QUATTRO SECURE MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R DTBA1Q1 CRTD, 5076 LEAD, 4298 LEAD