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

Model Number 97716

Device Problems Failure to Interrogate (1332); Overheating of Device (1437); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  malfunction  

Event Description

It was reported that there are some issues with the controller and recharger (rtm) over the past 2 months, where the patient (pt) reported the following: can't find ins with rtm, but then finds device and is charging the ins but then stops charging the ins.Shows low battery but when pt checks again it shows ins has charge level enough (value can vary), controller changed languages when pt didn't even do anything.Today, during troubleshooting caller removed the rtm from controller but controller is still acting like it is charging the ins.Given some of these issues, determined to replace the controller.Sent email to repair for controller replacement.No symptoms were reported.Additional information was received from a manufacturer representative (rep).It was reported that the rep called in and noted the pt called caller yesterday because they could not get the new controller to work.Pt received new controller from repair yesterday and their issue persists--the pt moved their li battery to the new controller and followed instructions and the controller is getting 'stuck' on 'checking recharger' screen.A replacement recharger (rtm) was sent out.Additional information was received from a manufacturer representative (rep).It was reported that the rep called in with patient and stated that they have been sent a replacement recharger and a replacement controller, but nothing is working the way it should be still.Caller explained that their original recharger will get noticeably warm and won't consistently charge the implant anymore.Caller added that the replacement recharger plug is too big and when they plugged it into the original controller it pulled the port out.Caller stated they were able to put the port back in, but the recharger plug won't fit in anymore.Caller then added that the replacement controller they received would not advance past the "checking the recharger" screen no matter what they did.Caller stated the battery pack is the only thing they haven't gotten replaced.Agent had caller walk through each of the devices.Agent reviewed returning all of the other equipment to repair; caller noted they have an appointment with the rep on tuesday and will ensure they get everything working before sending back the other equipment.A replacement controller, recharger, and battery pack were sent out.No symptoms were reported.

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: 97755-s, serial/lot #:(b)(6), b3: date is approximate.Month and year are confirmed valid.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: 19041357
• MDR Text Key: 339382850
• Report Number: 3004209178-2024-08464
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315474
• UDI-Public: 00763000315474
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/04/2024
• Date Device Manufactured: 04/01/2022
• 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: 74 YR
• Patient Sex: Female