{ "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 MERGE WAS ACCEPTED, AND WHILE LOOKING AT THE POST-OPERATIVE SCAN, THE LEFT LEAD WAS 4 MM DEEP, WHILE THE RIGHT LEAD HAD NO ISSUES. THE SURGEON DETERMINED THAT THE LEAD WOULD NEED TO BE 'PULLED BACK' 4 MM. A REVISION SURGERY WAS PERFORMED FOR RETRACT THE LEAD 4 MM, AND ANOTHER POST OPERATIVE SCAN WAS TAKEN. WHEN THIS SCAN WAS MERGED IT WAS DETERMINED THAT THE LEAD WAS IN THE RIGHT SPOT." }, { "mdr_text_key": "323854559", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED ANS THIS ANALYSIS CONCLUDED THAT THE DEVICE BEHAVED AS EXPECTED. THE LEFT ELECTRODE HAD BEEN IMPLANTED TOO DEEP, BUT AFTER IT WAS MANUALLY RETRACTED BY THE SURGEON, IT WAS ACCURATELY POSITIONED. THE ACCURACY IN DEPTH DEPENDS ON THE METHOD OF IMPLANTATION. IN THIS CASE, THE ELEMENTS OF ANALYSIS INDICATE THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS." }, { "mdr_text_key": "218521148", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "218521149", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING EVENT OCCURRED AFTER A DBS CASE ON (B)(6) 2020 WITH THE CLINICAL REPRESENTATIVE (CR): THE POST-OPERATIVE CT SCAN WAS TAKEN AND MERGED TO THE PLAN. THE MERGE WAS ACCEPTED, AND WHILE LOOKING AT THE POST-OPERATIVE SCAN, THE LEFT LEAD WAS 4 MM DEEP, WHILE THE RIGHT LEAD HAD NO ISSUES. THE SURGEON DETERMINED THAT THE LEAD WOULD NEED TO BE 'PULLED BACK' 4 MM. A REVISION SURGERY WAS PERFORMED FOR RETRACT THE LEAD 4 MM, AND ANOTHER POST OPERATIVE SCAN WAS TAKEN. WHEN THIS SCAN WAS MERGED IT WAS DETERMINED THAT THE LEAD WAS IN THE RIGHT SPOT." } ], "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": "04/15/2021" } ] }