MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
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Event Date 06/23/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 977a260 lot# serial# (b)(4).Implanted: (b)(6) 2021 explanted: product type lead product id 977a260 lot# serial# (b)(4).Implanted: (b)(6) 2021 explanted: product type lead.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 multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient's implant site was swollen, and the patient was experiencing a lot of pain.The patient decided to go to the emergency room before coming to the physician's office.The health care professional spoke to the patient and er physician who reported that the site is infected.The patient was scheduled for explant at 11:00pm on (b)(6) 2021.
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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 from the manufacturing representative (rep) and it was reported that event term only indicates ¿infection of the device pocket".Symptoms of infection start date is (b)(6)2021.The device was explanted (b)(6)2021.
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Event Description
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It was reported that the site became aware of the infection on (b)(6) 2021.It was determined to be serious on (b)(6) 2021.The patient became hospitalized on (b)(6) 2021 and was discharged on (b)(6) 2021.It was noted that medications or treatments were administered.The device was not reprogramming.There was swelling and redness due to an infection of the device pocket.The device was explanted to resolve the issue, and it was noted to be resolved as of (b)(6) 2021.
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Manufacturer Narrative
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Continuation of d10: product id 977a260 lot# serial# (b)(6), implanted: (b)(6) 2021, product type lead.Product id 977a260, serial# (b)(6), implanted: (b)(6) 2021, 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 977a260, serial# (b)(6), implanted: (b)(6) 2021,product type lead product id 977a260 , serial# (b)(6), implanted: (b)(6) 2021, 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.It was reported patient infection at pocket not resolved.
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Search Alerts/Recalls
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