BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROME¿ HF CRT-D MRI SURESCAN¿

    MDR report key: 23200496 · Received October 2, 2025

    Report

    Report Number
    2182208-2025-05087
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    May 7, 2025
    Report Date
    October 2, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: MIDNIGHT PUNCTUAL TACHYCARDIA. NETHERLANDS HEART JOURNAL. 2025. 33:213¿214. DOI: 10.1007/S12471-025-01959-Y, 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 THE TIMING OF VENTRICULAR TACHYCARDIA (VT). THE AUTHORS DESCRIBED A PATIENT WHO EXPERIENCED THE ONSET OF VT WHICH OCCURRED EACH NIGHT AT MIDNIGHT WITH THE FINAL EPISODE APPROXIMATELY TWO AND A HALF HOURS LATER. THRESHOLD TESTING OF THE LEFT VENTRICULAR (LV) LEAD OCCURRED EACH NIGHT AT MIDNIGHT BY CAPTURE MANAGEMENT AND VT WAS INITIATED. THRESHOLD TESTING FAILED DUE TO VT AND IT WOULD RESTART EVERY THIRTY MINUTES, UP TO SIX ATTEMPTS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LV CAPTURE MANAGEMENT WAS PROGRAMMED OFF AND NO FURTHER VT EPISODES OCCURRED. THE DEVICE REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317844 CROME¿ HF CRT-D MRI SURESCAN¿ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC, INC. DTPC2D4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNKNOWN COMPETITOR LEADS.