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

Model Number 97715

Device Problems High impedance (1291); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

B3: event date is not known.Please see b5 for approximate date range, if applicable.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

It was reported that information was received from a patient's representative regarding an implantable neurostimulator (ins).The re ason for call was patient representative.Reported the patient had a shocking sensation going down their right leg since probably months ago, even with the implanted neurostimulators turned off.Pt rep noted they only felt the shocking sensation when the patient was sitting in a chair that lifted up the stairs and then their leg would be bothering them.Agent reviewed the stair lift potentially could be emitting emi to cause the issues.Patient didn't have any recent falls or traumas.Patient services specialist reviewed the role of the medtronic representative.And provided them with them the national answering services (nas) number for the patient's healthcare provider.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the manufacturing representative (rep). caller states today he discovered while checking the integrity of the system that contact 15 has impedance issue, noted specifically 0/15 shows 20,150ohms.Agent reviewed considerations around impedances as it relates to the shocking mentioned.Caller states that the pt is having a shocking sensation when they are using an automatic stairlift (seated lift that goes up flight of stairs) and this has been occurring for 4-5 months.Caller notes that the pt has significant neuropathy/radiculopathy.Agent reviewed emi considerations and noted stairlifts are not specifically addressed in labeling.Agent reviewed consulting with manufacturer of stair lift.

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 the manufacturer representative (rep) reporting that the cause of the shocking was not determined.It was stated that they do not know that the patient does not experience any electrical responses when they sitting the chairlift chair, but they do feel some sort of interference when they operate the stairlift.The shocking sensation was resolved as long as the patient does not use the chairlift.

• 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: 18955673
• MDR Text Key: 338684208
• Report Number: 3004209178-2024-07575
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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: 02/27/2024
• Date Device Manufactured: 05/17/2023
• 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
• Patient Weight: 100 KG