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

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Overheating of Device (1437); Failure to Power Up (1476); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)

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

Event Date 09/12/2021

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that  the battery pack and controller are not working.Patient (pt) said they were trying to use the controller to charge their implant, but it would not activate at all.Pt put controller away to try again later, and when they took it out again, the controller was hot to the touch.Pt said they pulled the battery pack out of the controller and they could see on a portion of the battery pack that had burned through.Pt reported the controller was not charging, and would not power on with aa batteries.Pt reported the compartment door of the controller was tough to open.An email was sent to the repair department to replace the controller and battery pack.Additional information was received from the patient.Pt got the new battery pack and controller and went to charge the controller with the ac power cord and then the new battery pack started getting extremely hot, so they took it out so the same thing didn't happen to the battery pack and controller.Issue appears to be the ac power cord, which they said it was kind of bent.Ps s emailed repair to send out new ac power cord.The patient reported that they were using the replacement controller and li battery pack to charge their implanted neurostimulator (ins), but the controller and li battery pack were still getting hot to the touch, especially by the arrow up/down buttons on the bottom of the controller and the entire bottom of the controller.Pt was charging the controller during the call and the screen was dim on the controller.Pt could barely see the lettering on the screen.Pt mentioned the controller had "cooled off" after charging on the ac power supply for a while.Send repair replacement email for the controller, the recharger antenna, and the li battery pack.Additional information was received and it was reported that they tried all their new equipment with their ac power supply, but said started to make the clicking sound, and the screen of the controller started going crazy.Pt confirmed they were plugged into the ac power supply when that happened.

Manufacturer Narrative

Continuation of d10: product id 97745bp serial# (b)(6) product type accessory product id 97745 serial# (b)(6) product type programmer, patient product id 97745ac serial# unknown product type accessory product id 97755 serial# (b)(6) product type recharger product id 97745 serial# (b)(6) product type programmer, patient product id 97745bp serial# (b)(6) product type accessory product id 97745ac serial# unknown product type accessory section d information references the main component of the system.Other relevant device(s) are: product id: 97745, serial/lot #: (b)(6), udi#: (b)(4) ; product id: 97745, serial/lot #: (b)(6), udi#: (b)(4) ; product id: 97745bp, serial/lot #: (b)(6), b3: date is approximate h3: analysis of the controller (product id 97745 lot# serial# (b)(6)) found a dead main board/pcb.Analysis of the controller ( product id 97745 lot# serial# (b)(6)) found the main board was locked up.Analysis of the battery pack (product id 97745bp serial# (b)(6)) found no anomalies.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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: 18952608
• MDR Text Key: 339322315
• Report Number: 3004209178-2024-07553
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• 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: 61 YR
• Patient Sex: Male