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

Model Number 97715

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); High impedance (1291); Migration or Expulsion of Device (1395); Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Charging Problem (2892); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330); Electric Shock (2554); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial #: (b)(6), ubd: 20-oct-2027, udi#: (b)(4); product id: 977a260, serial#: (b)(6), ubd: 20-oct-2027, udi#: (b)(4).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.

Event Description

2024-feb-29: information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for spinal pain indications.Pt reports the other day they were sitting and the device dang near shocked them and were getting settings not available in all a, b and c.  pt states it was a very uncomfortable surge.Pt states it did go away but now getting these other codes when trying to adjust.Agent directed to hcp. pt states they cannot adjust either of those groups and that's all they get.Patient said the therapy is not working this time.Pt states they are very dissatisfied from this whole thing and mentioned just having the device explanted.Pt was very upset during call and unhappy with the device.Pt states they would rather just suffer with the pain then with deal with this.Pt states they are not any farther ahead then when they had the device implanted.Pt states they did xrays and noticed had moved slightly.Patient said the other day they were sitting in their recliner when they got a surge and then it just went away.The other day they had the terrible sensation.Patient said when they turned the stimulation up the vibration stimulation lasted a few minutes then they grabbed a controller and said they were using group b and the patient turned it down and it seemed to work.Patient was going to turn it up again and it didn't go back up to where they had the settings at.Patient tried a different group and that was out of the top of their head so they went to group a and it was the same thing.Pt mentioned they have to charge once per day and when really working they had to charge twice per day.Patient also mentioned they have a bad shoulder and can't get it adjusted so they can plug the belt in and turn it down but they dont feel anything on all the settings.Pt mentioned having nerve blocks done on their shoulder.Patient has groups a, b, and c but doesn't use them.Pt states the manufacturer representative (rep) had programmed where they don't feel stim.Pt states 1 and 2 are lower then 3 and 4.Pt states they just dont feel stim in the chair or anything.Patient is disappointed with the equipment and said it is the most inconvenient piece of charging equipment they could ever get out of their location.The issue was not resolved through troubleshooting.The patient was r edirected to their healthcare provider to further address the issue.Patient said they have an appointment with the healthcare provider in april.Patient stated they are getting relief but they are completely not satisfied with the therapy.Patient asked if there is a failure rate and were redirected to their healthcare provider (hcp).Pt states the last time they determined some of the leads burnt out.Pt states they went over to see the rep and the rep programmed around it as some of the electrodes were out.Pt states was working alright after that. pt reports something must be working as their ins has gone down in the battery level.Rep reported the patient had low impedance or a short. the impedances were all avoid.Patient had a loss of stimulation.The cause of the low impedance is known; patient had a fall after their appointment in (b)(6).Patient also had a return of pain, issue is ongoing.The submitted impedance report displays that some impedances were at 40,000 and above 17,000 ohms.2024-mar-20: additional information was received from a manufacturer representative (rep).The rep clarified the electrodes were out/burnt out; the patient was referring to the impedance issues.X-ray showed the leads moved down half a vertebral body.The cause was determined to be from the patient¿s fall; caused it and the impedances were found after the fall.Rep programmed around the impedances to provide continued stimulation.Issue is not resolved; the patient is coming in to the clinic next week because they are unable to adjust their settings with the new programming rep did.Rep will run another impedance test at that time.

• 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: 19000782
• MDR Text Key: 339888882
• Report Number: 3004209178-2024-08065
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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
• Date Manufacturer Received: 02/29/2024
• Date Device Manufactured: 11/10/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 110 KG