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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 12/10/2023

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 (pt) regarding the external device.It was reported that their device does not stay consistently charging.Patient stated that they called 2 months ago and it worked for a while until december 10th then charging was working very sporadically.The implant would not fully charge since that date.Patient reported that they tried charging again this morning and it acted up on them and they got system problem rm06.Patient noted that the controller worked for the whole hour and then the controller went down to 60% from 100% within the hour.The implant only charged to 30% according to the patient.Agent walked patient through resetting the controller.Patient confirmed that there were no visible damage to the recharger wire or teeth.Patient attempted to start a recharging session of their implant and reported poor recharge quality.Patient repositioned the antenna and was able to start recharging with excellent quality.Then controller displayed a message that the battery was low and needed to be replaced.The controller was at 50% and the implant was at 30%.The errors only occurred during recharge sessions.The issue was not resolved through troubleshooting.A replacement recharger (rtm) was sent out.No symptoms were reported.Pt called back stating they were not able to charge the implant.It starts good and flashes and charging and maybe after 2-3 minutes it says 'not able to charge'.It goes back and forth.After an hour the controller battery drains down to zero but the implant was only at 40%.Pt kept getting poor recharge quality message.Pt said the recharger was replaced.Pt tried the new paddle in the 3rd week of january and it was good for 2 days.Then pt started having charging issues where it cannot charge or cannot find the device.This morning pt tried using the old recharger.It was doing well but after an hour battery pack depleted but the ins was still at 40%.Pt mentioned they also had other rtm replacements in the past and usually resolved the issue but not this time.Pt saw no damage.An email was sent to repair to replace the controller.Patient called back and stated they received the replacement controller and couldn't get the controller to register to charge the implant.During the call there were no damages on the recharger and controller charging port.Patient reset the controller then plugged the recharger.Patient kept getting no device found then 46/73/84 on the passive recharge mode screen.Patient was able to recharge at excellent.Controller was at 90% and implant had a red triangle.Agent closed case.Pt called back and reported their controller had reverted back to the beginning of the pairing process every time they go to use controller.Pt was able to successfully find the device and complete pairing process; then saw no device found.Pt began passive recharge mode (prm) like yesterday and saw50/57/59.After repositioning a little they got to 65/66/67 but couldn't get higher - mentioned they got up around 80 yesterday.Pt repeated previously documented information and said they were unhappy with their implant due to the ongoing issues they had already reported (see case history).Pt mentioned they had been receiving letters from medtronic to follow-up on prior reports as well, but they felt they weren't being listed to.Agent reviewed information and confirmed for pt that all their reports were being documented.Pt mentioned yesterday after they got the ins charged to ~40% they charged the controller and then didn't attempt to charge again because they had struggled with the controller making them go through pairing process again.Pt noted yesterday they 'felt a zing in their leg' and knew stimulation was on, but they weren't feeling anything today; agent reviewed ins probably got too low and turned off stim, thus they are going back through prm.Pt confirmed green light was flashing on controller and eventually progressed to regular battery screen - controller was 80% and ins was red/low.Pt asked if charging usually takes an hour for other people; agent reviewed information.Pt then got 'poor recharge quality' and said they'd keep trying to charge, but the sensitivity of the paddles was very frustrating, and they had a hard time maintaining connection both when charging and when just trying to use their controller.Agent redirected pt to their hcp, and maybe to meet with a medtronic rep, to further address the difficulty they have with connectivity, since both controller and recharger had been replaced, but they were still experiencing these issues.

Event Description

Additional information received from the patient.Patient called back stated they are still unable to connect controller by itself to their implant.Agent confirmed patient has not met with hcp and mdt rep for further assistance.Agent reviewed device function and recommended contacting hcp for next steps.

Manufacturer Narrative

Concomitant medical products: product id 97745nt, lot#/serial# (b)(6),product type product id 97755-s, lot#/serial# (b)(6), product type recharger 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

Additional information was received from a patient (pt).It was reported that they were sent a new paddle and it did not provide consistent charging.It was difficult to charge in a timely manner.They were then sent a controller and there was still no reliability in charging.They were told to contact the manufacturer representative (rep) or doctor as it may be a problem with the internal equipment.The pt stated that the new controller will find the device when hooked up to the charging equipment.Controller will check battery, levels, program settings, program levels.They can get their stimulator charged but not timely.Their lower back pain continues to restrict their activities.No pain improvement since stimulator was installed.

Manufacturer Narrative

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: 18887880
• MDR Text Key: 337650717
• Report Number: 3004209178-2024-06898
• 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,Followup,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2024
• Date Device Manufactured: 01/24/2022
• 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...."
• Patient Age: 63 YR
• Patient Weight: 159 KG