Continuation of d10: product id 9735670 (serial: (b)(6); product type: ; implant date n/a; explant date n/a h3, h6); no parts have been returned to the manufacturer for analysis.Applicable codes: b17, c20, d15 multiple fdd/annex a codes were reported.A0709 was coded for the allegation of intermittent tracking.A05 was coded for the allegation of the camera not tracking when expected.A0902 was coded for the allegation that the images were going black.A1102 was coded for the allegation the firmware incompatibility and illuminator current measured lower than recommended error messages.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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H2) continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735821.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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