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); No Device Output (1435); Failure to Power Up (1476); Charging Problem (2892); Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996); Data Problem (3196)

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

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 ; product id m995402a001 (serial: (b)(6)).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.It was reported that they have two stimulators and their thoracic stimulator will not turn on.Patient noted that the controller will not turn on for the thoracic stimulator.Troubleshooting was unable to be performed as patient disconnected the call.Agent attempted to call patient back but had to leave a voicemail. patient called back and the issue and did not provide an event date but did state that a couple days or a week ago the controller was working.Patient didn't recall anything plugged in to the controller when the issue occurred.Patient texted a manufacturer representative (rep) 4 days ago.Agent had a lot of difficulty collecting information from the patient because patient would not answer straightforwardly.Patient stated they were pulling up to the house.Agent placed patient on a hold so patient could gather equipment for troubleshooting.Multiple calls; patient also kept disconnecting the call.Patient would like the stimulators taken out but needed an mri.Patient was very frustrated about their equipment.Patient also noted they couldn't hear the agent and broke their phone trying to gather equipment.Agent gave patient the option to gather equipment again.Patient.Disconnected the call again. pt called back from number registered repeating issue with controller not turning on.Pt said they figured out to take the battery out, then put back in and plugged into ac power and the controller came on again.Patient said the controller had been unresponsive for about a week and so they hadn't been able to charge their left stimulator either. patient reported memory problem on the call and was able to set date/time.Patient then saw no device found.Agent reviewed to let controller charge, then charge the implant.Agent reviewed no device found troubleshooting with patient if needed later. patient stated that they let their controller charge using the ac power supply, but when they unplugged the controller, it became unresponsive again.Agent walked patient through plugging the controller into the ac power supply without the battery pack.Patient confirmed they see a green light on ac power supply box, and the controller powers on when plugged in without li battery pack.When patient reinserted the battery pack, they stated there is no light that turns on above the controller screen.Patient inserted their other controllers battery pack into the controller and the green flashing light began to blink.The issue was not resolved.A replacement battery pack was sent out.

Manufacturer Narrative

H3: analysis of the battery pack found device scrapped due to not charging in known good unit.No anomalies were visually observed.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

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

Additional information was received from a patient (pt).It was reported that the cause of the left stimulator not powering on.The patient also reported that they only have one paddle for recharging.The patient also mentioned the situation has caused distress, anxiety, mental anguish, and that they were exhausted.Additional information was received from a patient (pt).It was reported that the battery needed to be charged but they also had requested a replacement recharger/paddle because it overheats.The pt reported that this presents a danger when trying to charge their body because the cord causes the exterior of their body to heat up.

• 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: 19095871
• MDR Text Key: 340804101
• Report Number: 3004209178-2024-08982
• 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
• 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: 07/14/2022
• 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: 04/01/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• 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 Sex: Female