MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Failure to Deliver Energy (1211); Energy Output Problem (1431); Difficult to Remove (1528); Application Program Problem (2880)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/24/2023 |
Event Type
Injury
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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) for non-malignant pain.Caller is with pt today and notes the pt's stimulation got weaker and 'just stopped' without any event/issue prompting this.The pt had checked to confirm it was on, pt charged the ins.The caller checked impedances today and they were all 'green' with a broad range of 620-3000ohms.The caller noted he tried programming on all 4 available electrodes at 300usec 80hz with bipoles, double guarded cathodes, etc, but the pt only felt stimulation 'for a moment but it went away'.The caller notes getting oor around 6ma when turning stim up.The caller will look to do imaging at this time.(b)(6)2023: additional information was received from a manufacturer representative (rep).The rep reported that the cause of the out of regulation message and stimulation just stopping was not determined.Rep tried different electrode configurations and adjusted settings.Impedances were all normal and in range.The issue is not resolved.The provided information has been confirmed with the physician/account.
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Manufacturer Narrative
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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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Additional information was received on september 8, 2023.The rep reported that the pt was going to have the system replaced on (b)(6) 2023.During the explant procedure the surgeon had difficulty accessing and removing the paddle lead, so they decided to only do the explant portion on (b)(6) 2023.The replacement surgery will occur soon (date of replacement surgery was not provided).
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Manufacturer Narrative
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Continuation of d10: product id 3587a lot# l58159 implanted: (b)(6) 1999 explanted: (b)(6) 2023 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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Manufacturer Narrative
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Continuation of d10: product id 3587a lot# l58159 serial# implanted: (b)(6) 1999, explanted: (b)(6) 2023, 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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Device was discarded.Oor message resolved by lowering intensity.Unable to obtain patient weight.Physician was notified and was there of event.
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Search Alerts/Recalls
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