MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Tingling (2171); Therapeutic Response, Decreased (2271); Electric Shock (2554); Paresthesia (4421); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2020 |
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) 2020, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 09-mar-2024, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 27-feb-2024, 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 consumer via a manufacturer representative regarding a patient with an implantable neurostimulator ( ins).It was reported there was loss of therapy effectiveness, shocking sensations mid back, and tingling between the two incision sites.The issues were more on groups a and b than c with differential target multiplexed (dtm) spinal cord stimulation.There was no environmental, external, or patient factors that may have led to the event.Dtm was reprogrammed without success, x-ray turned stimulation off for the day as well.The patient did not experience the shocking sensation mid back or tingling between operative sites on the day that stimulation was turned off.The issue was not resolved at the time of report.The physician noted the leads had migrated approximately 1 vertebral body down so the tips were at the top of t9 rather than the top of t8.
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Manufacturer Narrative
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Continuation of d11: product id 977a260 lot# serial#(b)(6), implanted: (b)(6) 2020, explanted: product type lead product id 977a260 lot# serial# #(b)(6), implanted: (b)(6) 2020, explanted: 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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Additional information received.Rep spoke with patient (b)(6) 2020 and patient reported ¿shocking¿ in the pocket when battery is on.
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Manufacturer Narrative
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Continuation of d11: product id 977a260, serial# (b)(6) implanted: (b)(6) 2020, product type lead.Product id 977a260, serial# (b)(6) implanted: (b)(6) 2020, product type lead.H3: company representative was report source for new information reported on 10/29/2020.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 977a260 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2020 product type lead product id 977a260 serial# (b)(6) implanted: (b)(6) 2020 explanted: (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 rep reported that the leads were revised on the day of the report.The explanted leads would be returned.
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Manufacturer Narrative
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H3: analysis of the leads determined that there was no significant anomaly.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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