It was reported that on 2021-feb-10, once the mer recording was performed, then the lead contacts were checked for thresholds for benefit and side effect.Thresholds checked in bipolar configuration (monopolar/bipolar) at pw of 90 and frequency of 135: contact 0: 5v, the patient could not tolerate amplitudes greater than 7v, so further ot testing was deferred.The patient experienced eyelid closing.Contact 1 and contact 2: 6.8v - patient experienced hand pulling.Contact 3: open.There was no stimulation-induced side effect up to 10v/patient experienced no side effects.The left dbs lead was uneventful.On (b)(6) 2021, the patient presented for scheduled implantation of their right side dbs lead but inspection of their recent left frontal scalp incision site showed a small dehiscence at the posterior aspect of the incision and compressing the surrounding scalp results in expression of a small amount of apparently purulent exudate.The patient elected to defer their scheduled right dbs lead implantation procedure and proceeded with elliptical excision and primary repair of the poorly healing, apparently infected wound dehiscence site with attempted preservation of the dbs hardware.There was no appreciable purulence after excision of the small area of dehiscence and no evidence of contamination of the dbs hardware.The patient was treated with antibiotics for 3 weeks and the site healed well without evidence of infection.The right dbs lead was rescheduled for (b)(6) 2021.
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Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id 3387s-40 (lot: va2a5mj); product type: 0200-lead; implant date (b)(6) 2021; medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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