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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Device Difficult to Program or Calibrate (1496); Delayed Charge Time (2586)

Patient Problems Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 01/10/2024

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 friend/family member who was implanted with an implantable neurostimulator (ins).The reason for call was caller reported that patient had (unrelated) triple bypass surgery several weeks ago and is in the recovery stage.Caller reported that about a week before the surgery the patient told them that their stimulator wasn't working.The caller stated that they tried to get the patient to call in and get some help but the patient was not able to get help from anyone when they tried to call.Caller mentioned that one primary thing with recovering is walking around in order to get well.Now the patient is home in (unrelated) rehab and can't walk around because patient hurts too much and their stimulator was not working.Caller noted that it's a real dire situation and they are fearful for the patient's health and recovery if they can't walkaround like they are asked to.Agent asked if caller was not with the patient, and did not know any other event information other than the patient told them "not working at all" and that they were not able to program or do something.Agent reviewed with patient rep to have patient call in to patient services, but patient had already tried and asked if someone can reach out to the patient. agent called out to patient per patient rep request.Patient answered and confirmed they finally got the implant charging today with help of a rep.Patient mentioned it took a while to get to 70% so patient stopped before being fully charged.At one point, patient went to use the controller again and described the memory problem screen.Six weeks ago patient said the stimulation stopped working and patient tried 2-3 times to get charging going but just kept failing.Patient mentioned their back was extremely tender and sore and described as feeling like their nerves are jammed.Patient said their implant usually helps with the pain, but this is a stronger pain than what the implant usually helps with.Patient mentioned the pain was off and on, but 2 days ago got very extreme.Patient said they turned stimulation on for a little bit after they charged up earlier, but ended up turning stimulation off due to stim not helping.Patient mentioned they are currently using a tens unit on their side and hips to try and help with back pain.Patient is going to try and get back pain down before turning stimulation back on and increasing intensity.Agent reviewed if stimulation still did not help with the pain to follow up with doctor and rep.Patient confirmed doctor on file is correct.

• 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: 18944125
• MDR Text Key: 338998337
• Report Number: 3004209178-2024-07447
• 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: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Date Device Manufactured: 03/10/2018
• 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: 79 YR
• Patient Sex: Male