Concomitant medical products: product id :977a260, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 11-dec-2024, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 19-nov-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information was received from the healthcare provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).Patient reported to hcp that the stimulator was not helping and getting sensations in the side.X-ray had confirmed that both leads had migrated down two levels. patient said he didn't fall and doesn't recall any event that moved the leads.Hcp states that he isn't careful and might be trying to avoid a jail sentence. x-ray was performed about a week before the lead revision. leads were replaced because manufacturer doesn't make revision kits anymore and stylets and needles were needed, so the new leads were used. leads were replaced, old ones discarded.System is implanted and in use.Patient went home after surgery.The issue resolved.
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