MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97715

Device Problems High impedance (1291); Energy Output Problem (1431); Low impedance (2285)

Patient Problems Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 02-sep-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that upon placing lead into epidural canal and connected to the ipg, connectivity checked ok and impedances on electrodes wnl until ipg placed in pocket and electrodes 1,3 measured 10 ohms.Confirmed leads wiped off, replaced and torqued.Same occurrence.Identified saline irrigation was used, and vancomycin powder was placed in pocket and midline spine incision.Dr mcdougall decided to continue procedure as patient had gotten adequate coverage prior to procedure.After placing supine and in pacu, impedances again checked and again electrode 1,3 indicate ¿avoid¿ and now electrodes 5.6,7,8 indicate ¿do not use¿ and electrode 12 ¿avoid.¿ impedances were over 40k,  and other contacts were elevated.

Event Description

Additional information was received.It was reported at an appointment with the patient the tablet reported no impedance issues at all.All 16 contacts on the 565 lead were within normal limit's and were green.The patient was programmed over the entire lead, however only rib stimulation was received.The patient never experienced paresthesia down their legs.The healthcare provider told the patient that the led and ins were behaving well and there was no manufacturer issues.They noted it had to do with the patient's anatomy.The healthcare provider was set to go back in next week and wither trial on the table with the percutaneous leads, to see if they could get any stim or move the paddle down to a different level.The patient understood and was okay with the decision.

Manufacturer Narrative

Continuation of d10: product id: 977c165, lot#serial#: (b)(6), implanted: on (b)(6) 2016, explanted: on (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.

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.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 was received from the rep and it was reported that on the march 31st revision one lead was trial placed at t 11/12 and tested interop.Pt felt paresthesia in butt and bilateral legs and was happy.The hcp then disconnected the ins and lead the did a laminectomy at t12/l1 and the existing lead was placed at t11/12.Tunneled an reconnected to existing ipg.Connectivity and impedances were all green.9 days out the patient reports 90% pain relief and patient and hcp are happy.

Event Description

Additional information was received from the rep.The rep reported that all impedances were within normal limits.The rep was able to send stimulation anywhere on the lead without issue.All stimulation anywhere on the lead elicited rib stimulation.At the most caudal part of the lead, the rep could get a little leg stimulation, but rib stimulation was too high and not tolerable.The rep programmed dtm silent therapy at about 3ma.The hcp noted to let the dtm run for about a week then reassess next week.If the issue is not better, another revision might be done to replace the paddle lead with a percutaneous lead.

Manufacturer Narrative

Continuation of d10: product id 977c165 lot# serial# (b)(6) implanted: (b)(6) 2016 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 was received from a rep.The rep reported that there was a short (10 ohms) on contacts 1 and 3.Additional information received on 2021-03-15 stated that it was unknown why the issue was occurring again.The rep was to meet with the patient on (b)(6) 2021 to see if impedances change.

Manufacturer Narrative

Continuation of d10: product id 977c165 lot# serial# (b)(6) implanted: (b)(6) 2016 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.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11483794
• MDR Text Key: 239780878
• Report Number: 3004209178-2021-04282
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 03/12/2021; 03/17/2021; 03/23/2021; 04/09/2021
• Supplement Dates FDA Received: 03/16/2021; 03/18/2021; 03/25/2021; 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 86