BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿

    MDR report key: 22844075 · Received August 19, 2025

    Report

    Report Number
    9614453-2025-03279
    Event Type
    Death
    Date Received
    August 19, 2025
    Date of Event
    July 5, 2023
    Report Date
    August 19, 2025
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    UDI-DI
    00763000178109
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 694765 LEAD IMPLANTED: (B)(6) 2011. 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 THAT THE PATIENT IS DECEASED. THE PATIENT¿S SPOUSE INDICATED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM THE PATIENT¿S LEGS BEGAN TO SEEP FLUID AND FORM BLISTERS AND WAS INSTRUCTED BY A PHYSICIAN TO ADMINISTER DIURETIC TWO TIMES A DAY. ADDITIONALLY, IT WAS STATED THAT LATER THE PATIENT EXPERIENCED A FALL AND COULD NO LONGER STAND. THE PATIENT PRESENTED TO THE HOSPITAL, PROCEDURES AND TEST WERE PERFORMED AND THE PATIENT WAS DIAGNOSED WITH AN INFECTED DEVICE, AND THE INFECTION OF SEPSIS AND STAPH HAD SPREAD THROUGHOUT THE PATIENT¿S SYSTEM. IT WAS ALSO REPORTED THAT MANY PROCEDURES INCLUDING DIALYSIS WERE PERFORMED, HOWEVER, THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252807 COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTPA2Q1 00763000178109

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention| H| D 439888 LEAD.