BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT¿ XT HF CRT-D MRI SURESCAN¿

    MDR report key: 24430527 · Received February 24, 2026

    Report

    Report Number
    9614453-2026-00746
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    February 4, 2026
    Report Date
    February 24, 2026
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    UDI-DI
    00763000178130
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0673 LEAD, IMPLANTED (B)(6) 2019. 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

    IT WAS REPORTED THAT THERAPY WAS WITHHELD/DELAYED DUE TO WAVELET AND SUPRA VENTRICULAR TACHYCARDIA (SVT)-ATRIAL FIBRILLATION (AF) THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). IT WAS NOTED THAT THE PATIENT HAD CHEST PAIN AND A HEART RATE OF ONE HUNDRED SIXTY BEATS PER MINUTE AND THE PATIENT WAS EXTERNALLY CARDIOVERTED. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327501 COBALT¿ XT HF CRT-D MRI SURESCAN¿ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTPA2D4 00763000178130

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Life Threatening 383069 LEAD, 5076-52 LEAD.