MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
|
Back to Search Results |
|
Model Number 97715 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problem
Pain (1994)
|
Event Date 05/12/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant products: product id:977a260, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 08-jun-2024, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 29-apr-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the ins and leads were explanted due to painful nonfunctioning ins.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 977a260 lot# serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type lead product id 977a260 lot# serial# (b)(6), implanted: (b)(6) 2020, explanted: (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.
|
|
Event Description
|
Additional information received from the healthcare provider reported that the patient was not getting relief from the device.The device was removed and the patient was referred to physical therapy.
|
|
Manufacturer Narrative
|
H3: analysis of the 97715 serial # (b)(6) found insignificant anomalies the implantable neurostimulator (ins) passed functional testing.Analysis of product id 977a260 lot# serial# (b)(6) found insignificant anomalies.Analysis of product type lead product id 977a 260 lot# serial# (b)(6) found insignificant anomalies.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.
|
|
Search Alerts/Recalls
|
|
|