{ "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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IT WAS REPORTED THAT THERE WAS INACCURATE REFERENCE, WHICH LED TO PATIENT HARM." }, { "mdr_text_key": "380729766", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A1-A4: PATIENT INFORMATION IS NOT AVAILABLE. B3: EVENT DATE IS NOT AVAILABLE. NOTIFY DATE IS POPULATED IN B3 AT THIS TIME. H3, H6: NO PARTS HAVE BEEN RETURNED FOR PRODUCT ANALYSIS. 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. 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