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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Difficult to Remove (1528); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id: 977a260, serial#: (b)(4), product type: lead.Product id: neu_unknown_lead, serial#: unknown, product type: lead.The main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 20-jan-2026, udi#: (b)(4).Product id: neu_unknown_lead, serial/lot #: unknown, ubd: 20-jan-2026.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

Information was received from a patient on (b)(6) 2022 who was implanted with an implantable neurostimulator (ins) for fbss leg/back and spinal pain indications.The reason for call was during the call the pt noted they had been in so much pain since implant date and their ins was not working (patient services specialist (pss) understood this as the pt was not receiving therapeutic relief).Pt met with a manufacturing representative for reprogramming today in person for 45 minutes and informed them of their issues (pss understood this as the pt had reprogramming done to their ins).Pss documenting reported information.Additional information was received again on 06/21/2022.Pt mentioned they were not getting therapeutic relief on the right side, where their pain was at, but was getting relief on the left side since implant date.Pt had met with mdt rep.The first time just after implant date and had called mdt rep.Many times about the issue.Pt mentioned they were "not getting much relief" from the spinal cord stimulator (scs).Pt also mentioned they had always had a terrible time connecting the recharger antenna (rtm) to the implanted neurostimulator(ins) to charge the ins.Pt said sometimes it took them 15 minutes to get the rtm connected to the ins.Pt mentioned, at first, they had to charge their ins every day for 1.5 hours, but now, the charge on their ins lasted a "week or more." pt mentioned they would be meeting with their hcp on thursday for x-rays.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the patient on (b)(6) 2022.They reported that they met with their doctor on the (b)(6) 2022 and had an x-ray done.The hcp told the pt the leads were in the right place.They were still having pain however, no steps have been done to correct the pain yet.Pt provided their weight.Physician listings were sent to the pt and the field was notified that the pt still needed assistance.The pt confirmed that the recharging issue was resolved.Additional information was received from the patient on (b)(6) 2022.Pt reported that they had a new healthcare provider (hcp) and that they were still having pain.Pt reported that their new hcp would move the leads from the left side of their spine to the right side where their pain is.After recharging issue was resolved, pt now only charges about every 2-3 weeks.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: explanted: product type lead product id 977a260 lot# serial# (b)(6) 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.

Event Description

Additional information was received from the manufacturer representative (rep).It was reported that the patient had a lead revision scheduled for lack of desired coverage to patient¿s pain pattern.The leads migrated/were dislodged.The patient had a loss of therapy and stimulation in an undesired location.The hcp had performed x-ray to visualize leads.Leads appeared to be located to the left of spine and patient¿s primary source of pain on the right.The hcp felt this could be resolved with lead revision with the goal of shifting leads to midline and right side.Hcp aborted revision intraoperatively due to difficulty accessing threading leads to desired location.He stated difficulty was due to ¿flimsy stylet.¿ the issue was resolved.Additional information was received from the patient.The patient said the leads couldn't be moved, they were removed instead as previous mentioned by the rep.The pain issue has not been resolved.

• 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: 15414552
• MDR Text Key: 299832210
• Report Number: 3004209178-2022-11758
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

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: 02/14/2023
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 11/10/2022
• Date Device Manufactured: 02/17/2022
• 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...."
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 109 KG