Model Number 97715 |
Device Problems
Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Undesired Nerve Stimulation (1980); Pain (1994)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical prodcuts: product id 977c265 lot# serial# (b)(4) implanted: (b)(6) 2020 explanted: product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 977c265, serial/lot #: (b)(4), ubd: 22-oct-2023, 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 via manufacturer representative who was implanted with an implantable neurostimulator (ins).It was reported that patient has increased pain in back and hips.Scs hasn¿t helped her pain per patient report.Rep met with patient to reprogram.Most electrodes elicit stim in flank and ribs.Using bottom 3 electrodes on lt.Array of 2x8 paddle lead and only able to obtain stim in rt leg.Patient to follow up with rep in 1-2 weeks to report if reprogramming more beneficial than previous settings.The hcp took an x-ray of lead this afternoon; top of lead is to the rt.Off of midline.Issue not resolved at this time.
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Manufacturer Narrative
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Continuation of d10: product id: 977c265; serial# (b)(6); implanted: (b)(6) 2020; product type: lead.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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Event Description
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The patient is scheduled to be seen and reprogrammed on (b)(6) 2021.She reports that she does acknowledge that prior programming offered some relief and she preferred the previous settings.The patient had recently been seen by a health care professional for consultation regarding her chronic pain.
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Search Alerts/Recalls
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