CARPEDIEM

Additional Manufacturer Narrative

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

ACCORDING TO THE REPORTER, THE MOTHER OF THE PATIENT TOLD THAT THE PATIENT HAD SEVERE LEG PAIN WITH DARK DISCOLORATION OF THE LEGS.

Additional Manufacturer Narrative

THE CARPEDIEM SYSTEM WAS GRANTED DE NOVO CLASSIFICATION BY THE US FDA ON APRIL 29, 2020, AND HAS BEEN CLASSIFIED AS CLASS II. AS SUCH, THE CARPEDIEM SYSTEM IS SUBJECT TO MEDICAL DEVICE REPORTING REQUIREMENTS (21 CFR 803). SINCE APRIL 2020, 5 (FIVE) COMPLAINTS WERE REGISTERED IN THE EU REGION. THESE EVENTS WERE APPROPRIATELY REPORTED TO THE RELEVANT COMPETENT AUTHORITIES WITHIN EU, IN COMPLIANCE WITH LOCAL VIGILANCE REQUIREMENTS. THE SAME EVENTS WERE NOT REPORTED TO THE US FDA, DUE TO AN INITIAL MISCLASSIFICATION OF THE DEVICE WITHIN THE COMPLAINT HANDLING SYSTEM. SPECIFICALLY, THE CARPEDIEM SYSTEM INVOLVED IN THE ABOVE-MENTIONED EVENTS WAS NOT IDENTIFIED AS A "SIMILAR DEVICE" TO THE ONE DISTRIBUTED IN THE US MARKET. THIS CLASSIFICATION ERROR LED TO THE ASSUMPTION THAT THE EVENTS WERE NOT REPORTABLE UNDER FDA¿S MEDICAL DEVICE REPORTING REQUIREMENTS, AND THE EVENTS WERE NOT REPORTED TO THE US FDA. MOZARC MEDICAL WILL, GOING FORTH AND RETROSPECTIVELY, COMPLY WITH ALL FDA ACT'S REQUIREMENTS INCLUDING MEDICAL DEVICE REPORTING (21 CFR 803) FOR THE CARPEDIEM SYSTEM. CORRECTION: B1, B2, D1, D4, H1. ADDITIONAL INFORMATION: G3. 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

ADDITIONAL INFORMATION: G3. NEW INFORMATION HAS BEEN RECEIVED PERTAINING TO THE EVENT. THIS EVENT HAS BEEN REASSESSED AND THE REPORTABILITY HAS BEEN DETERMINED TO BE A MALFUNCTION. 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.