BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 19120319 · Received April 16, 2024

    Report

    Report Number
    2182208-2024-01651
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    August 7, 2023
    Report Date
    April 16, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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. REFERENCED ARTICLE: ANTEGRADE APPROACH FOR PERIPHERAL INTRAVASCULAR LITHOTRIPSY PRETREATMENT TO FACILITATE LASER LEAD EXTRACTION. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2024. 67:243¿245. DOI: 10.1007/S10840-023-01617-6 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING LASER LEAD EXTRACTION WITH LITHOTRIPSY. THE AUTHORS DESCRIBED A PATIENT WHO DEVELOPED A POCKET INFECTION APPROXIMATELY TWO MONTHS POST IMPLANT. THE PATIENT WAS REFERRED FOR LASER LEAD EXTRACTION OF THEIR RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) LEADS. THE RA LEAD WAS DIFFICULT TO REMOVE. THERE WAS A PRESENCE OF DENSE ADHESIONS AND CALCIFICATIONS WHICH MADE EXTRACTION DIFFICULT, AND THEY USED PRETREATMENT WITH LITHOTRIPSY TO AID IN THE REMOVAL. THE LEADS WERE ALL EXTRACTED AND THE STATUS OF THE LEADS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856346 SPRINT QUATTRO SECURE MRI SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC, INC. 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention| H