Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins).It was reported that there were high impedances.All 8 contacts on right lead >40,000.There was stimulation in an incorrect location.Reprogramming was attempted.Patient in for lead revision.Right lead impedances has been >40,000.Patient began to feel stimulation in chest recently and saw physician.Rep was told about this on revision date, was not aware before.Physician noted left lead migration to c7 on x-ray.Patient also mentioned charging challenges and he stated he did not call into the patient service line.He stated he was getting ¿no device found¿ messaging frequently, he has been using/charging stimulator however it was not charged on revision date.Patient adamant about wanting battery replaced as well despite education.Physician also on board.Or made aware about sending in leads & ipg.Leads were cut.All product was placed in sharps container before rep could put it in appropriate p ackaging.The issue was resolved.
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Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(6), ubd: 29-apr-2023, udi#: (b)(4); product id: 9 77a275, serial/lot #: (b)(6), ubd: 10-jun-2023, 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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