BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT¿ HF QUAD CRT-D MRI SURESCAN¿

    MDR report key: 23314323 · Received October 16, 2025

    Report

    Report Number
    9614453-2025-04124
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 16, 2025
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    UDI-DI
    00763000178185
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. 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 A PATIENT REPRESENTATIVE THAT "EARLIER THIS SUMMER WE KEPT HEARING BEEPING. IT WAS THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). WE WENT TO THE CLINIC AND THEY CHECKED THE DEVICE AND SAID THERE WAS ONE YEAR LEFT OF THE BATTERY. THEY ALSO DID A CHEST XRAY AND EVERYTHING WAS GOOD. SHORTLY AFTER THAT THE DEVICE WAS BURNING THE PATIENT'S CHEST, THAT HAS GONE AWAY; NOW TODAY WE HAVE A LONG BEEP." IT WAS CONFIRMED THAT THE TONE THEY WERE HEARING WAS A STEADY TONE AND THE PATIENT/PATIENT REPRESENTATIVE WAS EDUCATED ON MAGNET TONE. IT WAS ALSO REPORTED THAT THE PATIENT DID HAVE A MAGNET NEAR THE CHEST. THE PATIENT WAS REFERRED TO THE HEART CLINIC/PHYSICIAN. 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
    2550412 COBALT¿ HF QUAD CRT-D MRI SURESCAN¿ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTPB2Q1 00763000178185

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other 407645 LEAD, 693558 LEAD, 479878 LEAD.