{ "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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PRIOR TO THE PROCEDURE, THE PATIENT APPEARED TO HAVE A HEPARIN REACTION AND EXPERIENCED A HYPOTENSIVE EVENT WITH A SYSTOLIC PRESSURE OF 39MM. THE SITE INITIATED A CARDIOPULMONARY BYPASS RUN AND COMPLETED THE PROCEDURE WITHOUT EVENT. WEAN FROM BYPASS WAS UNSUCCESSFUL AS PATIENT EXHIBITED STONE HEART CHARACTERISTICS. NO MALFUNCTION OF THE DAVINCI S SYSTEM WAS ALLEGED BY THE HOSPITAL, AND THE INFORMATION PROVIDED INDICATES THAT THIS EVENT IS RELATED TO THE INHERENT RISKS ASSOCIATED WITH BYPASS AND THE PATIENT'S MEDICAL HISTORY." }, { "mdr_text_key": "17545207", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IN 2008, INTUITIVE SURGICAL HAS REQUESTED ADDITIONAL INFORMATION RELATED TO THIS EVENT FROM THIS SITE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE HOSPITAL HAS CONTINUED TO USE THE DA VINCI S SYSTEM TO PERFORM SURGERY ON PATIENTS. AS OF 2008, NO ADVERSE EVENTS OR PRODUCT PROBLEMS HAVE BEEN EXPERIENCED WITH THE SITE'S DA VINCI S SYSTEM. AS OF 2008, NO SIMILAR INSTANCE OF THIS EVENT HAVE BEEN REPORTED TO ISI." } ], "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": "" } ] }