Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that there were low impedances, alert ¿avoid¿ was noted on contacts 0 & 11, 200.The contacts appear to be touching via x-ray and rep noted the leads crossed.Programming adjustments were done and the issue was resolved.The manufacturer representative (rep) indicated they would send any further information as they become aware.
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Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6), ubd: 18-sep-2027, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(6), ubd: 18-sep-2027, udi#: (b)(4).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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