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

Model Number 97715

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Battery Problem (2885); Charging Problem (2892); Data Problem (3196)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.The patient reported that the ins had been resetting itself to 0 while walking and when in a laying position, it automatically resets itself to a higher setting.The patient reported that because he was disabled and ¿because of the nerve damage and everything¿ this was less noticeable at home.The patient reported that this weekend he was able to get out and walk for a bit and the stimulation ¿reset itself at least 3-4 times.¿ the patient reported that he didn¿t walk a lot, walking was when he was in the most pain, so when he did, he ¿desperately¿ needed the therapy to work.The patient reported that when he was doing any walking at all, the therapy would reset itself to 0 which was ¿extremely painful¿ and was ¿stuck in midstride¿ with no stimulation until he could get stimulation turned back on again.The patient reported that ¿to have it stop working in the middle, it was unreal the pain that happened.¿ the patient also mentioned that the case for the controller was a little too bulky to put in his pocket, so he took the controller out.The patient reported that he thought maybe something was rubbing against the controller was changing the stimulation, so he put the controller back in the case, but the issue kept happening.The patient noted that he contacted a manufacturer¿s representative (rep) and was trying to set up an appointment to meet with her at the healthcare provider¿s (hcp) office.The patient reported that the rep said he may need to manually adjust settings before meeting with her.It was confirmed that the controller was displaying the correct position and amplitude.No further complications were reported.

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 from a manufacturer representative (rep).It was reported that the cause was not determined.Adaptive stim was turned off.The patient was advised to keep a log over a few weeks.The rep said therapy appeared fine.The patient texted the log to the rep: moving from setting a to c1 or a to c2 he will get no device found.This was logged everyday of patient's 15 day log.Patient also says he will see no device found when charging.It was advised the rep meet with the patient to examine and determine if the patient is doing everything according to best practices.It was reviewed that sometimes patients will cover the controller when trying to communicate or move it too far away from their body.Movement of the recharger while charging may also affect this as well.No further complications were reported.

Event Description

Additional information was received from a manufacturer¿s representative (rep).The rep reported that the therapy was turning on by itself.The rep reported that stimulation was surging randomly, very strong, and won¿t decrease until he used his controller to decrease.The increased stimulation wasn¿t related to position.The rep reported that the stimulation changed from group a to group b on its own.The rep ran impedances and they were all okay.The rep noted that the patient wasn¿t using the controller when he felt stimulation turnon/off.The rep reported that this was occurring daily.The rep reported that the patient used group a for night and group b for day.The adjustments registered for b at 65 and a at 168.The rep reported that the patient put the ins to group a to sleep and didn¿t adjust.The rep would continue to use stimulation with the same program without adaptive stimulation.No further complications werereported.

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.The patient reported that he was walking and the ins reset to 0 several times.The patient reported that he called a manufacturer¿s representative (rep) who texted him back and stated that there must be an issue with auto stimulation via text.The patient reported that after a week he was able to make a doctor¿s appointment which he was told he had to have in order to meet with a rep.Additional information was received from the patient on (b)(6).The patient reported that he had been having these events for over a month when he contacted a rep on (b0(6).The patient reported that when the ins stopped working and reset itself to 0 on its own, while in the stimulator case, while in his bag, while he was walking, which was the most painful thing he did, he has this happen several times in a day.The patient noted that he had an appointment on (b)(6).The patient reported that the auto stim was reset at that appointment and found that the was not the issue and we ended up turning it off.The patient reported that the rep at the (b)(6) appointment was able to reprogram the new c setting that he requested.The patient reported that that setting hadn¿t worked properly from the original placement of the device.The patient reported that he had been on manual stimulation since (b)(6).The rep asked the patient to keep a log for two weeks with any issues that he was having with the auto stim off.Over the next 15 days, the patient reported that there was a no device found screen, the ins was difficult to charge and he would get the no device found screen several times and he would have to start again.The patient reported that the new setting was taking a good deal more battery life as well, and he wanted to know if it was normal.The patient reported that he was getting no device found when the device was running and in normal day to day settings as well.No further complications were reported.

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.

• 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: 9409899
• MDR Text Key: 176565913
• Report Number: 3004209178-2019-23032
• 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
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 106