{ "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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THE PATIENT WAS DISCHARGED AND THEN READMITTED TO THE ICU AND DIAGNOSED WITH SEPSIS ON (B)(6) 2010 AND FOUND TO HAVE CANDIDA GLABRATA IN HIS BLOOD STREAM. THE PATIENT'S CONDITION WAS MANAGED WITH MICAFUNGIN PLUS ZOSYN AND FOLLOWED UP BY THE HOSPITAL'S INFECTIOUS DISEASE SERVICE. THE PATIENT WAS MOVED TO THE MEDICAL FLOOR ON (B)(6) 2010. THE PATIENT'S BLOOD GLUCOSE WAS LOW RANGING 45 MG/DL TO 80 MG/DL FOR THE PAST 24 HOURS, MANAGED WITH D50, BP 194/100 TO 152/100 TREATED WITH ATENOLOL AND LISINOPRIL. THE PATIENT ALSO DESCRIBED SOME SHORTNESS OF BREATH DURING EXERTION. A CT ANGIOGRAM OF THE PATIENT'S CHEST WAS PERFORMED ON (B)(6) 2010 AND RULED OUT A PULMONARY EMBOLISM. ON (B)(6) 2010, THE PHYSICIAN NOTES OFFICIALLY READ AS NO EVIDENCE OF PULMONARY EDEMA. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CURRENT STATUS." }, { "mdr_text_key": "22361364", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)64 )2010, FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL PROSTATECTOMY PROCEDURE." } ], "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": "" } ] }