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

Model Number 97715

Device Problems Electromagnetic Interference (1194); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Tingling (2171); Electric Shock (2554); Paresthesia (4421)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturing representative (rep) and a patient.The patient reported that they had a shocking sensation during their mri on the day of the report.They stated that they were in the hospital for new numbness and tingling.The patient mentioned that they placed the implantable neurostimulator (ins) into mri mode.They noted that when the mri began, they started getting a tingling sensation in their leg, so the mri was stopped.They noted that the tingling went away when they sat up on the mri table.The patient stated that their remote was still in mri mode at the end of the mri, and they were able to turn the ins back on with no issues.The issue was resolved at the time of the report.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider on february 5, 2021.They reported that on (b)(6) 2020, two hcps had verified that the implanted neurostimulator (ins) had been put into mri mode and had shown head-only eligibility prior to having the brain scan with a transmit/receive head coil.About a minute into the mri scan the patient had reported they felt stimulation turn on.The scan was stopped and the patient was removed from the scanner and checked out; everything was reported to be fine.The hcp was inquiring if other cases like this had been reported.Technical services sent a request to medical affairs to provide information to the hcp.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10348220
• MDR Text Key: 201207785
• Report Number: 3004209178-2020-13185
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR