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); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 03/24/2024

Event Type  malfunction  

Manufacturer Narrative

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.It was reported that they were attempting to pair their replacement controller with their implanted neurostimulator and they were unable to complete the process.Caller stated that they saw a batteries low message yesterday when they first attempted to pair the replacement controller to their implant, which they felt was in error because their controller was 100% charged.Agent walked caller through removing the battery pack and plugging controller into the ac power supply cord; caller confirmed controller powered on.Caller re-inserted the battery pack and confirmed solid green light above screen.Agent attempted to walk caller through pairing process; however, caller was unable to advance past the checking the recharger screen.Caller confirmed no visible damage to the recharger cord or pins.The issue was not resolved.A replacement recharger (rtm) was sent out.No symptoms were reported.  additional information was received from a patient (pt). pt called back for assistance with pairing instruction; said they kept getting stuck at 'checking recharge.' agent walked pt through resetting controller and confirmed all correct replacement equipment was being utilized.After reset and cleaning of connections, pt successfully got through checking recharger and saw no device found (but said they had been at 80% prior).Agent had pt select recharger and kept showing low connectivity numbers between 13 and 16.Pt confirmed proper placement of paddle.Agent allowed pt to continue charging on hold for a few minutes and checked back in, but no progress had been made on one full cycle of passive recharge mode.Agent reviewed meaning of numbers and advised they follow-up with their healthcare provider (hcp) to check position of the implantable neurostimulator (ins), as both controller and recharger had been replaced within the last couple days.Pt said they have appointment with hcp coming up and agent suggested a rep may want to meet with them as well and interrogate ins.Pt agreed and said may call a manufacturer representative (rep) to see about meeting at next appointment.

Event Description

Additional information was received from the patient.The pt called back and said they got replacement rtm and met with rep and everything was working but when they go to charge ins it just stays on checking recharger.Resetting does not fix the issue.Pt says they dropped the controller.Emailed repair to send replacement controller.

Manufacturer Narrative

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.

• 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: 19040262
• MDR Text Key: 339331967
• Report Number: 3004209178-2024-08439
• 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,Followup
• Report Date: 05/08/2024

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: 01/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/08/2024
• Date Device Manufactured: 02/05/2020
• 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 Age: 72 YR
• Patient Sex: Male