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

Model Number 97715

Device Problems Intermittent Continuity (1121); Energy Output Problem (1431); Patient Device Interaction Problem (4001)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Swelling/ Edema (4577)

Event Date 10/16/2023

Event Type  malfunction  

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

Information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for call was patient was recently implanted and had questions regarding therapy.Pt called patient services today to ask how therapy works.Therapy was turned on last monday.Pt wanted to know if it was normal that the vibration changed with the position even with arms up and down.Reviewed.Pt then reported they were not getting consistent relief of pain without going to pain level 7 or 8 every day since implanted (therapy turned on last monday).Pt has good moments with therapy but they do not last long every day.If pt sits with their feet on the floor and put them up the vibration increased.If pt goes to bed and try to lay on the back, the vibration goes up to the ceiling.Pt reported the vibration felt too strong sometimes.Pt feels comfortable on the left side or stomach.Pt was on given 3 groups to use each for a week.Pt used a last week and using b now.Pt is feeling the vibration in both knees and up their thighs a bit and a little bit in lower buttocks.On the call pt confirmed adaptive stim was not turned on yet.Reviewed first 6-8 weeks is healing time and it might be normal for stim feeling increase.Pt also mentioned they kept the intensity lower in the evening and increase in the morning before the pain starts.Pt mentioned they sleep well since pt had therapy on.When pt gets up in the morning, after 30 min the pain comes and can go up to pain level 7 or 8.Pt wanted to know if they should increase stim when the pain start or increase prior and weather pt should always increase when pain comes back.Reviewed each pt is different.Pt mentioned they were keeping a diary.This morning pt had stim at 1.4 on the left side and 1.5 on the right side.Pt had mild buzzing in both legs.Pt increased to 1.5 and 1.6 when the pain started.The vibration was tolerable.Then pain level went up and pt took a pain pill, within 2 hours pt took a tramadol.Then the pain level went up again.Sometimes pt takes tramadol or a spasm pill because sometimes they back spasms but usually just once per day.Last night pt took a shower in the evening and had to sit down as pt had more pain after that.It took a while for pain to go down to a tolerable level.The other day pt went to 1.7 and stim was too high.Lying on the back was c razy and got extremely strong.Pt also wanted to know if it was ok to use a bottle of hot water if one of the sides bother them.Pt reported when their pain goes to level 7-8, the area where ins is seems to swell a little bit/gets puffier but it goes down again.Pt said there is no discharge and scarring seems to be healing.Pt also had questions on programs and groups.Reviewed.Pt said they do not like using pain meds and their hope is the device will give them much more control and pt can get their life back.Reviewed info.Redirected to hcp.

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

Pt reported they did not have problems with the stimulator itself.They called as the stimulator was just turned on october 30th, patient had general questions regarding how to use it, all were answered.

• 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: 18152890
• MDR Text Key: 329571885
• Report Number: 3004209178-2023-21887
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2024
• Date Device Manufactured: 09/13/2023
• 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
• Patient Age: 77 YR