MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems Intermittent Continuity (1121); Failure to Interrogate (1332); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896)

Patient Problems Undesired Nerve Stimulation (1980); Distress (2329); Electric Shock (2554); Insufficient Information (4580)

Event Date 01/04/2024

Event Type  Injury  

Manufacturer Narrative

Date is approximate.Year is confirmed valid.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 who was implanted with an implantable neurostimulator (ins).The reason for call was patient stated they had revision surgery in january.Patient reported they are feeling electrical currents and shocks since march.Patient stated they can't touch a computer or cell phone.Patient stated they are feeling the stimulation on the left side all in the upper body.Agent reviewed device function and recommend patient consult with healthcare provider (hcp) office for next step.Patient services specialist asked patient to clarify and patient said the stimulator says stimulation is off.The patient was redirected to their healthcare provider to further address the issue. patient called back and added that they had spoken with  some manufacturer representative (rep) but keep being told to call the manufacturer.Patient noted they had met with a rep, and the rep set everything to 0.Patient noted that the electrical current sensation has stopped since then, but this morning they woke up at 1:30am and 2:45am getting zapped in the butt where the implant is locate d.Patient added that the "battery and the leads in my back are just going" and tingling inside of them.Patient stated that they have a problem with their legs and back, and no one is listening to them.Patient noted they just had the battery revised.Patient added that this morning stimulation was going up the middle of their spinal cord, but they didn't even touch the controller to turn it on.During the call, agent had patient verify the controller showed "stimulation is off." patient noted the controller battery is 40% and the implant battery is 90%.Patient commented that when they try to use the antenna to charge, it just says searching for device so they were told to get the antenna replaced.Patient continued to explain that they feel the stimulation despite stimulation being turned off, and that the device itself is tingling inside of them.Patient noted they were at the hcp  office, but they don't know anything about the device.Patient stated they don't want the device removed because they're afraid they're going to be bent over like before.Patient stated they're suffering and something must be wrong with their battery.Agent reviewed with patient that given their concerns and symptoms, they should follow up with their implanting physician.Patient stated they were being tossed around and no one could help them.Patient ultimately agreed to follow up with a different hcp.Agent advised patient to focus on the stimulation and device sensation concerns first before addressing any recharging questions.Agent sent an email to the field.

Event Description

Rep reported they learned about the issues in late (b)(6).Rep stated their colleague was made aware in (b)(6).The patient had the battery moved, nothing was switched out as the provider saw nothing wrong with the implanted system.Cause of feeling stim when off was not determined.Cause of revision was due to pt battery as placement was determined the error.

Manufacturer Narrative

G3: an update was made to correct the aware date.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: 19126465
• MDR Text Key: 340401927
• Report Number: 3004209178-2024-09255
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• 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: 03/25/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 05/16/2024
• Date Device Manufactured: 11/15/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female