{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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}, { "mdr_text_key": "337224910", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A4: PATIENT WEIGHT WAS UNAVAILABLE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO PERFORM A SYSTEM CHECK OUT AND THEY FOUND THAT THE SYSTEM FUNCTIONED AS INTENDED. NO PROBLEMS WERE DETECTED. B01, C19, D14 ARE APPLICABLE TO THE SYSTEM CHECKOUT. THE EXPORTS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS IS STILL IN PROGRESS. B21, C21, D16 ARE APPLICABLE TO THE CLINICAL ANALYSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "342324873", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: THE EXPORTS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS DETERMINED THAT THE PROBABLE CAUSE OF THE DEVIATION REPORTED IS A PATIENT SHIFT. 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." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1 HAESHEL STREET. (BUILDING C)", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55432", "manufacturer_contact_exchange": "612", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/13/2024" } ] }