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)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

Section d: references the main component of the system.Other medical products in use during the event include: brand name intellis; product id: 97755, (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

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was patient reported that they were unable to charge the ins since 2 days ago, and usually they left ins on 24/7.Patient said they had tried resetting the controller 3 or 4 times, but that did not resolve the issue and they couldn't get the controller to recognize the implant.Patient service specialist had patient start a recharging session.Patient reported seeing no device found.Patient pressed recharge and entered passive recharge mode with numbers 0-0-0.Patient moved the recharger antenna around and reported that the numbers went up to 94 and 89.Agent reviewed best practices for positioning recharger paddle, and pt said they always try centering ins in the hole.After a while, pt confirmed they progressed to normal charging screens; controller was 80%, ins was red/low and recharge quality was excellent.The troubleshooting steps that were taken on the call resolved the issue.Patient mentioned that they saw their health care provider yesterday, but they did not have a representative present.Agent reviewed with pt to let ins charge up.Additional information was received from the patient. pt reported the controller could still not find the device.Pt reported the recharger did get hot but it did not charge.An email was sent to repair to replace the recharger.

• 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: 19005776
• MDR Text Key: 339114738
• Report Number: 3004209178-2024-08139
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

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: 10/28/2022
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/29/2024
• Date Device Manufactured: 11/09/2021
• 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
• Treatment: "SEE H11"
• Patient Age: 78 YR
• Patient Sex: Female