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

Model Number 97715

Device Problems Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211)

Patient Problem Abdominal Pain (1685)

Event Type  malfunction  

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).Pt d they will charge fully one day and walk around and it doesn't help a great deal so pt doesn't notice when it's on or off.Patient will go to charge the next day and it hasn't gone down at all.Patient said they were told never to press the top button which is the stimulation on/off button, but pt will press the top button and the stimulation has been off so pt will set it back on and pt can kind of tell that it's working that day, but that happens every once in a while.Patient service specialist asked if patient has tried any other programs and patient said they haven't yet.Pt d they had abdominal wall pain from neuromas and during trial seemed to help at that time so went ahead and put the system in.Pt stated they had a bunch of programs and has not found the perfect program.Pt d they will have to try that yet.The patient was redirected to their healthcare provider to further address the issue.Pt did not have the name of the rep from the past they worked with who did some adjustments.Pt thinks it was done before summer 2023.Pt states hasn't dealt with reps since may 2023.Agent sent email to the reps.

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.

• 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: 19004699
• MDR Text Key: 339048113
• Report Number: 3004209178-2024-07965
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2024
• Date Device Manufactured: 08/11/2022
• 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