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); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Impedance Problem (2950); Insufficient Information (3190)

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

Event Date 03/08/2024

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 via manufacturer representative who was implanted with an implantable neurostimulator (ins).Caller reported patient called them last monday thinking it was their recharging issue and patient was getting replacement equipment.Caller reports patient has received two external controllers and two recharger paddles replacements.Caller reported patient continues to see no device found message.Caller reported patient called them last friday and met with them today.Caller reportsed they were able to interrogate the ins without any issue.Caller reported ins is at 70% charged.Caller reported they went into tech mode to disable and re-enable device, but did not resolve the issue.Caller reported when they connect to patient's implant using their communicator, when the rep used their communicator about 6 inches away from the ins, telemetry is lost immediately.Caller reported patient indicated nothing unusual has happened.No fall, no medical procedure, no travel, no new equipment around the house.Caller reported about 2.5 weeks ago, patient indicated this all started off and on.Caller reported when they interrogated patient's device, the stimulation is off, and caller reported patient's ins was discharged, therefore the ins had turned stimulation off.Patient has been attempting to connected to the ins by performing passive recharge, continue to see no device found.Agent suggested turning stimulation back on and interrogate impedance.Impedance shows: green: 8-15, avoid: 2, 3, 5, and 6.No electrodes that are showing do not use.Caller reported patient is programmed using electrodes 1 and 4.After turning stimulation on, agent suggested exiting workflow and attempted to connect using the patient's controller and recharger.Caller reported continues to see no device found.Agent suggested re-run impedance.Agent suggested obtaining files and session report.  on 2024-apr-09 patient called back stating that their rep had submitted a report a couple weeks ago with all the diagnostics, but they haven't heard anything back.Patient stated the implant hasn't been working for about a month.Agent reviewed information and patient services capabilities and redirected the patient back to their healthcare provider/rep to continue to address this issue.On 2024-apr-22 additional information was received from the rep.The rep reported the cause was not determined, the rep met with the patient to get logs, but has not have any communication on an update from the data.The rep provided software logs.The patient had no ability to connect the controller to the ins, it will only passively recharge and technical services did not have a resolution.

• 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: 19163641
• MDR Text Key: 341505393
• Report Number: 3004209178-2024-09588
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2024
• Date Device Manufactured: 01/13/2021
• 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 Age: 60 YR
• Patient Sex: Male