MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97716

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Pain (1994); Numbness (2415); Neck Pain (2433); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a290, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Product id: 977a290, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: 06-nov-2024, udi#: (b)(4).Product id: 977a290, serial/lot #: (b)(4), ubd: 24-sep-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that intra op for new implant and #1 electrode showing with "x" on connectivity check and >40k with all pairs on electrode msrmt.Other pairs normal and showing between 630-750 ohms for pairs with #0.This is brand new lead.Tss reviewed not counting on this electrode for programming so they would need to consider if they want to retain existing lead or use another new lead.Pt's weight is (b)(6) lbs.Dob of patient is (b)(6).Additional information was received from the manufacturing representative (rep) and it was reported that they left everything in.Patient had an mri on (b)(6) 2021 and it appears the leads are suspected to not be epidural according to healthcare provider (hcp) who updated rep on (b)(6) on this patient.They are going to take her to surgery on (b)(6) to revise the leads or remove them.

Event Description

Additional information received from the manufacturer representative reported that the system was explanted due to pain in the right arm.It was suspected that the leads were too far to the right.

Manufacturer Narrative

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.

Manufacturer Narrative

Product id 977a290 lot# serial# (b)(6) implanted: (b)(6)2021 explanted: (b)(6)2021 product type lead product id 977a290 lot# serial# (b)(6) implanted: (b)(6)2021 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

The patient came in for a post-op visit on (b)(6)2021.The stimulator was activated and the patient reported increased, sharp pain in the neck and head, and left arm numbness when the device was turned on.This was noted to be related to programming.An mri was ordered on (b)(6)2021.The device was turned off, and there was a plan to turn the device on after the mri.Imaging (an mri) was performed on (b)(6)2021.On (b)(6)2021, the results of the mri were reviewed with the manufacturer representative.Both leads were supposed to be epidural; however, the mri was questionable, and after the physicians reviewed the imaging, the position was assumed to be subdural according to them.The cause is not known.The leads were removed on (b)(6)2021 and new leads were implanted epidural by the physicians.The issues appear to be resolved as the leads were placed epidural.

Manufacturer Narrative

Analysis of product id 977a290 lot# serial# (b)(6) implanted: (b)(6)2021 explanted: (b)(6)2021 product type lead found broken conductors.Product id 977a290 lot# serial# (b)(6)implanted: (b)(6)2021 explanted: 2(b)(6)021 product type lead found 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.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11872799
• MDR Text Key: 252356503
• Report Number: 2182207-2021-00882
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781740
• UDI-Public: 00643169781740
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10."
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 72