Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor therapy and fecal incontinence.It was reported that they have been having pain since december.Patient stated that they had an x-ray, ultrasound, and ct scan and was told that everything looked good, however the gastro physician believed that the lead might have migrated away from the sacral nerve and had embedded itself.Patient inquired about lead/electrode specifications.Patient service specialist reviewed information and redirected patient to their healthcare provider to further address the issue.Reviewed with patient device information and patient confirmed that device information is current.
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Continuation of d10: product id 3889-28 lot# (b)(6) implanted: (b)(6) 2014.Explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(6), ubd: 13-feb-2018, 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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