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

Model Number 97715

Device Problems Disconnection (1171); High impedance (1291); Unintended Collision (1429); Positioning Problem (3009)

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

Event Date 12/12/2022

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that patient said they discovered over a year ago that one of the leads was not hooked up anymore.Additional information was received from the manufacturer representative (rep).Per rep, there was no knowledge of the leads not being hooked up; they were only aware of an impedance issue from that time that was reported.Rep confirmed they had spoken with the patient's primary doctor, and they had no reason to believe the lead had not been hooked up.

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.

Manufacturer Narrative

G3: correction to supplemental 001: correct aware date is 2024-01-31.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 patient (pt).It was reported that patient assumed the lead not being hooked up anymore was due to when they tripped down some stairs, causing the right lead to disconnect.Pt notes that they assume, but are not sure if that is what happened.Pt reports they recently had another fall; their legs went numb and they landed directly on the device as they fell.Since then, they have been in horrible pain.Pt says they will be seeing a surgeon very soon and plans to have surgery, that the battery pack (understood to mean the ins) was pushed in too far and the right lead will be reconnected at that time.Patient added that they have something in their left hip blocking them from standing up straight.

Manufacturer Narrative

Continuation of d10: product id 977a260, serial# (b)(6), implanted: (b)(6) 2018, 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 manufacturer representative (rep).The rep reported that the healthcare provider (hcp) was doing a lead revision.Prior to surgery the patient told the rep they fell about eight months ago.They had a fall on their left hip where the battery is located.Patient felt the fall on their battery was not allowing them to stand fully upright but that it caused them to lean to their right side.Rep mentioned this to the hcp and he said they have scoliosis which they did not have to this extent in 2018 when their original implant was and the scoliosis was preventing them from standing upright.In preop today, one lead had over 40,000 ohms on all eight contacts and the other lead had one contact with over 40,000 ohms.Both leads were replaced today in surgery.After the new leads were connected, one lead had the number eight contact with over 40,000 ohms.Hcp tried more than once to re-insert the leads and torque them down, but it did not resolve.He then swapped the lead positions in the battery ports and this time the number zero contact was over 40, 000 ohms.Hcp decided to leave the leads as they were since it was difficult to get the leads placed due to the patient¿s scoliosis in their spine.When the patient was awake in pacu, rep checked impedances again and all were within normal limits except for the zero contact.Rep was able to give the patient three different programs that covered their lower back where their chronic pain is located.The patient was happy with their coverage.Rep notified hcp that the patient had good coverage.

Manufacturer Narrative

D11: section d information references the main component of the system and other applicable components are the leads.Product id 977a260, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2024, product type lead product id 977a260, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2024, product type lead.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18463947
• MDR Text Key: 332300863
• Report Number: 3004209178-2024-00351
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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,Followup,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2024
• Date Device Manufactured: 04/11/2018
• 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 H11...."; "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 51 KG