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); 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 Type  malfunction  

Event Description

Information was received from a patient (pt) regarding an external device.The reason for call was patient reported trouble charging the implant.Patient said they have to reset controller 2- 3 times to get it to do anything.Patient also said they get a screen that says to call medtronic.Patient service specialist asked, patient said they don't know if there are any other codes on the screen.Pt states started a good while back and has gotten worse and worse.Agent advised to reset equipment and patient plugged controller in to ac power supply without li battery and reported the screen came on.Patient then reinserted li battery, and reported controller was 90% and implant was low.Patient tried to start a recharge session, but reported no device found.Patient moved the recharger around and reported getting the passive recharge mode screen and after a few minutes, patient reported the recharger got really hot where the cord goes into the paddle and could smell something, agent clarified if pt got burnt and pt states no just got hot and could smell it.The issue was not resolved through troubleshooting.A replacement recharger telemetry module (rtm) was sent out.

Manufacturer Narrative

B3: event date is not known.Please see b5 for approximate date range, if applicable.Continuation of d10: 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: 0213-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.

Manufacturer Narrative

Concomitant medical products: product id 97755 lot# serial# (b)(6)product type recharger h3: analysis of the recharger found cable insulation is peeling away at donut end and wires are exposed.No device found message.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.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: 19130197
• MDR Text Key: 340455184
• Report Number: 3004209178-2024-09276
• 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: Other
• Type of Report: Initial
• Report Date: 04/17/2024

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 Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/18/2024
• Date Device Manufactured: 11/17/2018
• 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...."; SEE H11...
• Patient Sex: Male
• Patient Weight: 116 KG