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)

Patient Problems Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

Information was received from a patient regarding an external device.The reason for call was patient reports her controller is not working and keeps saying no device found.Patient states she has been having a problem not fully charging.One time it would charge and the next time would only go so much percentage.Last night patient kept moving the paddle and it kept saying replace the controller battery.Patient also mentioned one night the recharger got real hot and controller got hot so she took it off.Patient service specialist advised to reset controller and after reset the controller was blinking green and showed implanted neurostimulator was low and controller 80%.Patient tried to start a recharge session and reported passive charge mode.The numbers did not change when patient moved the paddle around and pt was only seeing 0.The issue was not resolved through troubleshooting.An email was sent to the repair department.

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.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 product id 97745 lot# serial# (b)(6)product type programmer, patient h3: analysis of the recharger found recharger never got hot after running it for 10 mins.Got 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: 18978148
• MDR Text Key: 338592608
• Report Number: 3004209178-2024-07811
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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: 02/28/2023
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1535-2021
• Patient Sequence Number: 1
• Treatment: "SEE H11...."; SEE H11...
• Patient Age: 74 YR
• Patient Weight: 95 KG