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

Model Number 97715

Device Problems Energy Output Problem (1431); Use of Device Problem (1670); Charging Problem (2892); Positioning Problem (3009)

Patient Problems Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Pain (1994); Discomfort (2330); Impaired Healing (2378); Ambulation Difficulties (2544); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 977c165, serial#(b)(6), implanted: (b)(6) 2024, product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(6), ubd: 14-aug-2027, udi#: (b)(4).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 (ins).The reason for call was patient reported that the recovery was a little worse than they thought it would be.Pt mentioned their ins battery had to be charged more frequently than they thought and tries not to let ins get below 50%, and had to use belt because it's uncomfortable to hold paddle in place.Pt mentioned they thought they could still sense the impact of therapy for a little while after turning off.Patient reported that they were having a hard time getting out of bed and that they pulled something in their back.Patient stated that they dealt with 3-4 different reps and that the reps were very helpful; pt did not mentioned reporting charging frequency to reps, agent understood pt meant they had multiple reps involved in trial (mentioned speaking to a rep daily during trial) and programming of ins.Patient me ntioned that they had sciatica and that their hcp had a hard time getting one of the leads placed correctly to optimally help the right side sciatica.Patient noted that they still had some pain, but that it was way better than it was before they got the implant, and they were still seeing how their healing process would go.Patient asked, agent reviewed mri, x-ray, and other compatibility information with the patient and redirected to healthcare provider with further questions related to healing.  patient said their back is so bad that they feel like a fragile little child and cannot lift things like packs of water yet.Patient mentioned having the implant hasn't been good for their mental health, because they can't do certain things and worry aboutbeing 'fragile'.Pt mentioned the winter weather might be making their body feel worse.Patient commented that they spoke to the healthcare provider and the representative shortly after the surgery and they were told that they might get a scar, but they didn't care, and they were very pleased with the therapy and the pain relief they were getting insofar.Agent understood discomfort was due to the healing of implant site.

• 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: 18993032
• MDR Text Key: 339144527
• Report Number: 3004209178-2024-07993
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Date Device Manufactured: 01/23/2024
• 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
• Treatment: "SEE H11...."
• Patient Age: 63 YR
• Patient Sex: Male