{ "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 FULL ANALYSIS OF THE LOGS HAS BEEN PERFORMED. A REVISION SURGERY WAS PERFORMED ON (B)(6) AND ANOTHER COMPLAINT WAS RAISED REGARDING AN INACCURACY (IN DEPTH) OF THE ELECTRODES IMPLANTATION. BASED ON THE INVESTIGATION PERFORMED FOR BOTH DATES, THE ROOT CAUSE OF THE REPORTED INACCURACIES COULD NOT BE CONCLUSIVELY DETERMINED. THE ROOT CAUSE FOR THE DEPTH ERROR REMAINS UNKNOWN. A POSSIBLE EXPLANATION WOULD BE THE CHANGE IN THE DESIGN OF PMT BOLT CAPS AND THE PMT METHOD OF CALCULATION FOR THE ELECTRODES' LENGTH, ALTHOUGH THESE HYPOTHESES COULD NOT BE CONFIRMED. CORRECTED DATA: - B4 DATE OF THIS REPORT. - G4 DATE RECEIVED BY MANUFACTURER. - H2 IF FOLLOW-UP, WHAT TYPE .- H3 DEVICE EVALUATED BY MANUFACTURER. - H6 EVENT PROBLEM AND EVALUATION CODES. - H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "321557671", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT 2 ELECTRODES IMPLANTED, ABORTED PROCEDURE AFTER THIRD TRAJECTORY. POST-OP SCAN INDICATED BOTH ELECTRODES WERE DEEP ROUGHLY 3-5MM." }, { "mdr_text_key": "189880914", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "189880915", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT 2 ELECTRODES IMPLANTED, ABORTED PROCEDURE AFTER THIRD TRAJECTORY. POST-OP SCAN INDICATED BOTH ELECTRODES WERE DEEP ROUGHLY 3-5MM." } ], "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": "11/25/2020" } ] }