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); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 97745 , serial# (b)(6), type programmer, patient.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).Analysis of the 97745 controller (b)(6) revealed that the stim button bosses on the case front were broken and the lithium ion battery contacts were broken/damaged on the main board.Both items needed to be replaced.This regulatory report is being submitted as part of a retrospective review as part of a remediation plan 411 action.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

It was reported that the patient reported they were having issues charging their controller and the patient couldn't give an exact event date but the controller absolutely stopped working maybe (b)(6).Patient stated they would reset the controller to resolve the issue but now the controller wasn't charging.During the call patient denied visible damages in the controller charging port, ac power supply cord, battery, and battery compartment.Patient plugged the ac power supply cord into the outlet and denied green light on the box.Patient tried a different outlet and the green light displayed on the box.Patient plugged the controller into ac power and the controller did not power on.The issue was not resolved.A replacement controller was sent out.Additional information was received from the pt.Pt called back stating they were sent a controller; however, it¿s still not charging from the wall and the controller does not light up without battery pack to the wall.A replacement battery pack and ac power supply were sent out.Additional information received from the patient.Pt called back because they received the replacement equipment from this case, but kept seeing the "no device found" message when trying to connect wirelessly to the implanted neurostimulator (ins) no matter how close the controller was to their ins (patient services specialist (pss) understood this as the ins battery was depleted).Pss had the pt initiate a recharge session to their ins with excellent quality.Pt noted the controller battery was at 90%, but their ins battery was orange.Pss reviewed the external equipment was functioning as intended.Pss suggested the pt monitor their device and call back if necessary.Additional information was received from a patient (pt).It was reported that since the last time she received her replacement controller, she is not able to access her controller remotely.Caller reports the replacement was sometimes towards the end of (b)(6), early (b)(6).Caller reports she has a hard time recharging finding the location to charge her implant but is able to recharge.Caller reports she is now charging: controller 70% ins 60% caller was able to turn stimulation on with the recharger attached.Redirect caller to patient's hcp to re-pair her controller.Additional information was received from a patient (pt).It was reported that their physician could not help and they met with their manufacturer representative (rep).A room was made available to meet their rep but they had to meet twice because they needed to charge their device.The pt reported that the issue has been resolved and all is good now.

• 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: 18584687
• MDR Text Key: 334367064
• Report Number: 3004209178-2024-02261
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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 Sex: Female
• Patient Weight: 100 KG