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); Electromagnetic Compatibility Problem (2927)

Patient Problem Insufficient Information (4580)

Event Date 02/29/2024

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 multiple sources (patient, manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that there was interference with the ventilator.Message left on the rep's voice mail from patient stating, "i've been a spinal stimulator patient at the pain clinic.I had been put on a ventilator for approximately 2 years.The ventilator mask and ventilator system had magnets init, and it created a magnetic field.It would impact my stimulator.I didn't realize what was going on.But, anyway, i got notice from ventilator company that this would happen.And no one warned me about it prior to that.I'm probably going to have to change my ventilator system completely so there's no magnetic field.I wanted to let you know this, since my spinal stimulator was impacted by my ventilator system.The name of it is astral 150 resmed ventilator and mask system.The mask had magnets in it and it created a magnetic field and it did impact my stimulator.Please put this in my record so you will have a record of it.The patient called patient services and inquired about the potential for damage to the devices and the magnetic field that could cause them to have issues.Agent reviewed compatibility information with caller.Caller mentioned they have lung failure and have to use the ventilator due to that.Caller mentioned that on and off stimulation has felt different than before and  that they think that the ventilator has affected their stimulation.Caller reported it doesn't seem like the same pulse and/or sensation for probably 2 years.

• 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: 18951696
• MDR Text Key: 338708574
• Report Number: 3004209178-2024-07532
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• 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 Expiration Date: 04/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Date Device Manufactured: 05/10/2018
• 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: 73 YR
• Patient Sex: Male