BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿

    MDR report key: 24619063 · Received March 17, 2026

    Report

    Report Number
    9614453-2026-01046
    Event Type
    Death
    Date Received
    March 17, 2026
    Date of Event
    February 17, 2026
    Report Date
    April 21, 2026
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    UDI-DI
    00763000178093
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE PATIENT PASSED AWAY. THE PATIENT'S REPRESENTATIVE NOTED THAT THE PATIENT JUST FROZE STANDING UP IN THE BATHROOM" AND HAD TO LOWER THE PATIENT DOWN TO THE FLOOR.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT DIED FROM A HEART ATTACK, A CONDITION, PER THE PHYSICIAN, THE CRT-D WOULD NOT PROTECT AGAINST. NO CARDIAC ARREST WAS NOTED AND NO PERFORMANCE ISSUES WERE NOTED WITH THE CRT-D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108153 COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTPA2QQ 00763000178093

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Death 5076-45 LEAD, 429888 LEAD, 6935M55 LEAD