BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPIA MRI CRT-D SURESCAN

    MDR report key: 19578159 · Received June 20, 2024

    Report

    Report Number
    9614453-2024-02376
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    June 18, 2024
    Report Date
    June 20, 2024
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 3830 LEAD IMPLANTED: (B)(6) 2023 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE FOLLOW UP APPOINTMENT, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY LONGEVITY STATUS BAR WAS GRAY AFTER INTERROGATION, INDICATING LOW BATTERY VOLTAGE. IT WAS NOTED THAT THE REMAINING LONGEVITY DISPLAYED QUESTION MARKS. THE DEVICE 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
    1762121 COMPIA MRI CRT-D SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTMC2D4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 695M LEAD.