BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT¿ XT HF CRT-D MRI SURESCAN¿

    MDR report key: 18972109 · Received March 25, 2024

    Report

    Report Number
    9614453-2024-01191
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    January 17, 2024
    Report Date
    March 25, 2024
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    UDI-DI
    00763000178147
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0125 LEAD IMPLANTED (B)(6) 2003 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 FAMILY MEMBER, THAT EVER SINCE A ROUTINE DEVICE CHANGE OUT THE PATIENT HAS "HAD TERRIBLE HOT FLASHES AND DIZZY SPELLS." THE PATIENT WAS SHOCKED WHILE BEING ADMITTED, THEIR HEART RATE "WAS STUCK ON 156," "WAS PUKING OR CHOKING," AND THEN "WENT UNRESPONSIVE." THEY STATED "WE REALLY THINK THERE IS A PROBLEM WITH THE DEVICE." THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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
    460686 COBALT¿ XT HF CRT-D MRI SURESCAN¿ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTPA2D1 00763000178147

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization| L 5076-52 LEAD, 1258T86 LEAD