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Model Number 97715 |
Device Problems
Failure to Deliver Energy (1211); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 977a260.Serial# (b)(4).Implanted: (b)(6) 2021.Explanted: (b)(6) 2022.Product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 14-apr-2025, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient wanted more right side coverage.Dr replaced lead and implanted more on the right side.Patient is only receiving coverage on left side on both leads.Patient had an accident at work that could have caused the change.Diagnostics/troubleshooting performed and interventions/actions that were taken to resolve the issue was reprogramming.Patient was reprogrammed to hd, was only able to get right side coverage for lb, hip, and leg.Dr ordered x-ray to check lead placement. additionally, after patient's accident patient had increased pain, and his battery location and changed stim pattern to only the left side.Patient is getting nothing on the right.Talked with dr about moving the 8 through 15 leads on the right side and keeping 0 through 7 leads in place as this is where patient's programs are currently set that are helping him.Dr recommend will do pocket revision with batter site is to help with pocket pain.There were no impedance issues.Surgical intervention occurred and the issue was resolved.
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Manufacturer Narrative
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H10: the g3 date in the initial was incorrect and should be 2022-mar-25.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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