{ "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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A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NEUROLOGIST CLAIMED THAT AN MRI OF THE PATIENT'S BRAIN PERFORMED 4 YEARS LATER REVEALED POSSIBLE METALLIC MICRO-EMBOLI. HOWEVER, THE CAUSE OF THE ALLEGED POST-OPERATIVE METALLIC MICRO-EMBOLI IS UNKNOWN." }, { "mdr_text_key": "40186439", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING A CLINICAL LITERATURE REVIEW AN ARTICLE REFERENCED THAT POST A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN 2005, THE PATIENT PRESENTED TO A NEUROLOGIST IN 2009 WITH A HEADACHE. THE PATIENT HAD REPORTEDLY UNDERGOING CARDIAC CATHETERIZATION ON AN UNSPECIFIED DATE IN 2004. AN MRI OF THE PATIENT'S BRAIN SHOWED MULTIPLE MICRO-HEMORRHAGES. A CT-SCAN OF THE PATIENT'S HEAD WAS NEGATIVE. AN MRI PERFORMED IN 2003 DID NOT DEMONSTRATE ANY OF THE LESIONS. THE NEUROLOGIST PRESUMED THAT THE MRI FINDINGS WERE RELATED TO METALLIC MICRO-EMBOLI INSTEAD OF MICRO-HEMORRHAGES. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }