MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97716 |
Device Problems
Failure to Deliver Energy (1211); Entrapment of Device (1212); Migration or Expulsion of Device (1395); Low impedance (2285)
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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 product: product id 977a260 serial# (b)(6) implanted: (b)(6) 2023 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2023 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6), ubd: 08-sep-2026, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(6) , ubd: 03-dec-2026, udi#: (b)(4).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.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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Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that there were possible shorts open at 8 (410) and 11 (460).Patient denies trips falls accidents.Connection check all green.Patient not able to perceive stimulation on electrodes 0-7.There was a return of pain.Patient reprogrammed utilizing electrodes on 8-15 lead.The issue is ongoing.The manufacturer representative (rep) indicated they would send any further information as they become aware.Additional information was received from the manufacturer representative (rep).It was reported that it was unknown if effective therapy was established.Additional information was received stating patient presented today for a lead revision.Fluro image revealed both leads had migrated.Initially at implant, both leads were at t8.Imaging showed one lead had wrapped around the battery and one lead was at t12.Leads removed and replaced with a surgical paddle.
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Manufacturer Narrative
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H3: analysis of the electrical stimulation lead (serial number (b)(6)) found the lead body was cut through.Analysis of the elec trical stimulation lead (serial number (b)(6)) found the lead body was cut through.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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