BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSESELECT

    MDR report key: 20193319 · Received September 11, 2024

    Report

    Report Number
    3002648230-2024-00418
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    September 5, 2024
    Report Date
    December 3, 2024
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    QZI
    PMA / PMN Number
    P230017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    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

    PRODUCT EVENT SUMMARY: THE PATIENT DATA FILES WERE RETURNED AND ANALYZED. NO ERROR MESSAGES WERE FOUND IN THE DATA FILES ON THE REPORTED EVENT DATE. IN CONCLUSION, THE CLINICAL ISSUE OF PHRENIC NERVE PALSY (PNP) OCCURRED DURING THE PROCEDURE WITH NO INDICATION THAT THE ADVERSE EVENT WAS RELATED TO THE PERFORMANCE OR A MALFUNCTION OF THE PRODUCT. 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 DURING A PULSED FIELD ABLATION PROCEDURE, THE PATIENT'S PHRENIC NERVE WAS STUNNED. IT WAS NOTED THAT BASELINE PHRENIC NERVE WAS NOT OBSERVED BUT THE PHRENIC NERVE TEST PULSE WAS PERFORMED FOR EACH ABLATION IN THE RIGHT SIDED PULMONARY VEINS. FLUOROSCOPY IMAGES WERE TAKEN AND IT WAS OBSERVED THAT THE RIGHT DIAPHRAGM WAS ELEVATED BUT WAS NOT MOVING SYMMETRICALLY IN STRENGTH WITH THE LEFT SIDE. A HIGH OUTPUT PACING CATHETER WAS PUT INTO USE TO DETERMINE PHRENIC NERVE CAPTURE BUT WAS UNSUCCESSFUL. AFTER A WAITING PERIOD, THE RIGHT DIAPHRAGM FUNCTION WAS SLOWLY RECOVERING. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. IT WAS NOTED THAT POST PROCEDURE, THE PATIENT HAD A BILATERAL CHEST RISE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MONITORING. THE FOLLOWING DAY, A CHEST X-RAY WAS PERFORMED AND WAS NORMAL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574473 PULSESELECT PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC CRYOCATH LP PSCC100 0012387361

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization