BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBALT¿ DR MRI SURESCAN¿

    MDR report key: 24745771 · Received March 31, 2026

    Report

    Report Number
    9614453-2026-01220
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 9, 2026
    Report Date
    March 31, 2026
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LWS
    UDI-DI
    00763000178390
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT COMMUNICATION/TELEMETRY WAS NOT POSSIBLE WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT REPRESENTATIVE NOTED A DISCONNECTED MONITOR NOTICE. A KEY EXCHANGE RESET WAS REQUIRED (KER). CONNECTION WITH THE ICD WAS STILL NOT SUCCESSFUL. A BUSY ERROR WAS OBSERVED. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809846 COBALT¿ DR MRI SURESCAN¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC EUROPE SARL DDPB3D4 00763000178390

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female 407652 LEAD, 6935M62 LEAD