BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARIA MRI CRT-D SURESCAN

    MDR report key: 19845628 · Received July 26, 2024

    Report

    Report Number
    9614453-2024-02874
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 4, 2024
    Report Date
    September 6, 2024
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    CORRECTION: H6 EVAL CODE CONCLUSION (FDC/ANNEX D). 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 RECEIVED A MASSAGE AND "FELT THE [CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)] GOT DISL ODGED." THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT A DISLODGEMENT OR MIGRATION OF THE DEVICE WAS NOT CONFIRMED. THE PATIENT WAS SEEN IN THE EMERGENCY ROOM AND AN X-RAY THAT WAS TAKEN WAS FINE. THE PATIENT HAS ALSO CONTINUED REMOTE FOLLOW-UP .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458950 CLARIA MRI CRT-D SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTMA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female 5076-52 LEAD, 419488 LEAD, 6935M62 LEAD