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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Irritability (2421); Ambulation Difficulties (2544); No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 25-jun-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that the patient's implantable neurostimulator (ins) was depleting too quickly and therefore he was having to charge too often.Patient stated that he had to charge his ins every day and that was much more often than his previous ins.Patient stated he talked to his rep about this and the rep stated patient just had to get used to having a battery that was smaller.Patient also had 16 electrode lead now vs.His previous 4 electrode lead.Patient stated that therapy was good and he wanted to keep his settings where they were because if he didn't he wouldn't be able to feel his foot or walk.Patient services reviewed information about recharger frequency and how device settings can effect recharger interval and redirected patient to hcp.Patient has an appointment on (b)(6) and stated he would like to have his system checked because he was worried something could be wrong.Additional information was received from a consumer on 2020-sept-08 reporting that the patient had been in a car accident.The lead moved which caused pain that felt like an ice pick.A surgery was scheduled for (b)(6) 2020 to fix the issue.

Manufacturer Narrative

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

Event Description

Additional information was received.Patient responded back from follow up sent.Patient reported they were (b)(6) at the time of event.Patient reported they didn't realize that when they went back and had x-ray of their back after surgery, the old lead that was left in back because of the scar tissue they couldn't get it out.The new wire wiggles its way and is hitting the old wire so patient will have a part of the old lead taken out on (b)(6).Surgery will be done to correct the problem.

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 patient.Patient reported they have neuropathy and because of that has a lot of pain and wanted to reach out to reps about reprogramming.

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported the patient met with their manufacturer representative on (b)(6) 2020 for reprogramming because the ins battery was depleting more quickly than it used to, patient was programmed to group b.The evening they came home from reprogramming it was working for them and they were able to do aerobics and move in different directions they could not move in before and it did not hurt.The next day the pain in the patient's back had completely transferred from where it had been on their left side to their right side.The patient was told their ins battery was supposed to last 3-4 days but the new programming on group b was lasting 2 days.The patient changed their programming back to where they had it on group a.

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 patient and it was reported that the patient met with the healthcare provider (hcp) on (b)(6) and the manufacturing representative (rep) for reprogramming because the ins was losing way more electricity than he thought (clarified ins battery decreasing faster than he thought; at least halfway over night.) the patient said he has noticed this since implant, and that ins was working pretty good other than "balance" was off and got him to where he could urinate better.

Event Description

Additional information was received from the patient and it was reported that "the issue feels like a light stick pointing out of your skin".

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

Concomitant medical product: product id 977c165 lot# serial# (b)(6) implanted: (b)(6) 2018 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 patient.The patient said the previous lead was left in their body and they were wondering if it should have been.The patient stated that it was aggravating them.

• 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: 10525853
• MDR Text Key: 206767859
• Report Number: 3004209178-2020-15820
• 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: 03/08/2021

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: 06/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 09/23/2020; 11/13/2020; 11/16/2020; 12/15/2020; 12/29/2020; 03/01/2021
• Supplement Dates FDA Received: 09/25/2020; 11/17/2020; 11/19/2020; 12/16/2020; 01/04/2021; 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10".
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 93