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

Model Number 97715

Device Problems Failure to Interrogate (1332); Failure to Power Up (1476); Use of Device Problem (1670); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996)

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 97755 lot# serial# (b)(6) 1n implanted: explanted: product type recharger product id 97745 lot# serial# (b)(6) implanted: explanted: product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(6), ubd: , udi#: (b)(4) ; product id: 97745, serial/lot #: (b)(6), ubd: , 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

Information was received from a patient regarding an external device.The patient reported that the controller was not turning on.Last night patient had issues charging their implant, and saw error replace controller batteries.Patient had to reset the controller, but was only able to get their implant charged to 50% before the controller became unresponsive.During the call the patient removed the battery pack and plugged the controller into the ac power supply, patient confirmed the controller powered on.Patient put the battery back into the controller and confirmed the green light was flashing on the controller.Agent had patient start up a charging session and patient first saw the no device found screen, then could not get past the reposition recharger and looking for device screens.The issue was not resolved.A replacement recharger was sent out. patient called back stating that their controller will not turn on and is unresponsive.In order to get controller screen to turn on, patient has to reset the controller every time.Patient confirmed controller will not turn on when using up or down key to wake controller up, or when plugged into the ac power supply.A replacement controller was sent out.  patient reiterated that the controller was showing replace controller batteries error message.Agent reviewed screen meaning with the patient again.

• 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: 18997069
• MDR Text Key: 339295273
• Report Number: 3004209178-2024-07961
• 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: 03/27/2024

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?: No
• 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: 03/14/2024
• Date Device Manufactured: 04/13/2019
• 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: 87 YR
• Patient Sex: Male