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

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced ¿recurrent problems with her adaptivestim (as)¿ device.It was noted the issues started following a lead replacement procedure on (b)(6) 2021, during which the implantable neurostimulator (ins) was stated to have ¿become disoriented when removed and replaced in to the pocket.¿ the ins was reported to have ¿misinterpreted the orientation as well as turned the stimulation to 0.0 or up too high very randomly.¿ the patient¿s settings were reset and the device reoriented from scratch multiple times, but the issue remained unresolved.It was further noted that the ins was reprogrammed completely or just reoriented and that the as transition time was reduced to 30 seconds.The ins pocket was expected to be snug and stable in the reporting manufacturer representative¿s (rep) opinion, as the pocket was was not revised and an absorbable antibacterial envelope was added during the revision procedure.The patient was booked for further review the week of (b)(6) 2021.The rep planned to make sure none of the patient¿s programmed values were set to 0.0 ma and to increase the as transition time from 30 seconds during the meeting.The patient was instructed to check that their orientation was correct each time and the rep planned to check this again during their planned meeting.There were no further complications reported or anticipated.

Event Description

Additional information was received from the rep.It was reported that the rep reviewed the patient on (b)(6) 2021.The patient reported an issue with the device determining lying right and reclining, otherwise "check position" checks have been showing the correct patient position.The intensity seemed to be all over the place and very random.Steps taken on (b)(6) 2021 were: data reports pre and post reprogramming which were provided, a session report for the reprogramming which was provided (the patient's programming was simplified to a low frequency option only as the other lead had migrated again and required a second revision surgery to reposition), reconfigured and reorientated the adaptive stimulation settings on program a3, ensured no positions were set to 0.0 milliamperes (ma), stability time set to 30 seconds as the patient required as quick changes to settings as possible, transition times all set to their lowest (0 to 30 seconds), checked with patient controller that the device correctly identified patient position and adjusted intensity (these seemed fine in testing), and advised the patient to go and test further to ensure that this has been resolved.The patient had a revision surgery booked for lead replacement on (b)(6) 2021.Review of the data reports did not show anything abnormal.

Manufacturer Narrative

Concomitant medical products: product id 977a2 lot# serial# unknown implanted: 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.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: product type lead h2 correction: please note the lead information captured above (see reference d10) has been updated at this time.H6: please note that annex f code f1905 has been replaced with code f1904 at this time.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 stated that the lead would ¿hopefully just be moved, not replaced on oct-08.¿ it was noted that this was confirmed with the physician.No further complications were reported or anticipated.

Event Description

Additional information was received from the rep confirming the revision surgery was done on october 8th.The as was reset and appeared to be working as expected now.

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 received reported that the patient¿s lead was replaced on 2021-oct-08.No further event information was reported; there were no additional complications reported or anticipated.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6).Implanted: (b)(6) 2021.Explanted: (b)(6) 2021.Product type lead h6: please not that annex f code f1904 has been replaced by code f1905 at this time.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12500132
• MDR Text Key: 272909675
• Report Number: 3004209178-2021-14128
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/23/2022

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: 02/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 09/21/2021; 09/22/2021; 01/19/2022; 05/18/2022
• Supplement Dates FDA Received: 09/22/2021; 09/23/2021; 01/20/2022; 05/23/2022
• Date Device Manufactured: 03/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Female