BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S MRI SURESCAN

    MDR report key: 9949984 · Received April 10, 2020

    Report

    Report Number
    2182208-2020-00704
    Event Type
    Injury
    Date Received
    April 10, 2020
    Date of Event
    January 1, 2020
    Report Date
    April 23, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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 WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: INAPPROPRIATE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SHOCKS DUE TO ATRIAL FAR-FIELD ON THE TIP-TO-RING CHANNEL FOR LEAD DISLODGEMENT JOURNAL OF ARRHYTHMIA. 2019; 35(3):562-564. 10.1002/JOA3.12180. 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 A DEFIBRILLATOR AND LEAD. THE AUTHORS DISCUSSED A CASE WHERE TEN DAYS POST IMPLANT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS WHICH OCCURRED AT REST. IT WAS DETERMINED THERE WAS FAST ELECTRICAL ACTIVITY CONSISTENT WITH ATRIAL FAR FIELD WHICH WAS IDENTIFIED AS VENTRICULAR FIBRILLATION. TRACE RECORDS SHOWED THERE WAS VENTRICULAR ACTIVITY WITH BACKGROUND NOISE DUE TO THE ¿FLOATING LEAD,¿ WHICH HAD DISLODGED INTO THE OUTFLOW TRACK. ADDITIONALLY, THERE WAS A REDUCTION IN PACING IMPEDANCE. THE DEFIBRILLATOR WAS DEACTIVATED. FOLLOWING, THE LEAD WAS RE-POSITIONED WITH COMPLETE RESOLUTION OF THE PROBLEM. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411965 SPRINT QUATTRO SECURE S MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6935M

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R VISIA AF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR