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

Model Number 97715

Device Problems Overheating of Device (1437); Environmental Compatibility Problem (2929); Impedance Problem (2950)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 01/25/2020

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 manufacturer representative (rep) concerning patient with an implantable neurostimulator (ins).It was reported that patient she had a non-related back surgery (b)(6) 2020 and since then has had a burning sensation at the ins implant site.Patient states it feels like the ins is burning inside.Patient states the burning sensation is when stim is on or off.Patient reported that after the non-related back surgery on (b)(6) 2020, the healthcare provider (hcp) told her he cut the wire.Before the patient went home the hcp told her he did not cut the wire and said when she gets home to go ahead and charge the ins.Patient is able to charge the ins just fine.Patient states she has left the therapy off since implant because she was afraid to use it.Patient states she turned stimulation on "the other day" and still has the burning sensation.Patient states last night the burning sensation was so bad and painful she could not roll over in bed and could hardly even get out of bed and she just wanted to cry.Patient states she has had no falls or trauma.Manufacturer representative (rep) states per the ins log, the is a 1% usage for the last 30 days.Patient states she has not had stimulation turned on.Rep stated he has checked the impedances on the leads and they seem fine.1 1050 ohms 2 1170 3 1170 4 1160 5 1210 6 1270 7 1210 8 1230 9 1240 10 1210 11 1130 12 1310 13 1330 14 1350 15 1350 it was reviewed with rep that since burning sensation is at the pocket whether therapy is on or off, especially since rep has confirmed that usage was off during the time that therapy is off, the conclusion is that burning sensation is not from the ins, but rather medical in nature.Rep also said she palpated along the system and it didn't elicit any sensation, other than at the pocket site.The rep was told that the impedance values look suspicious since they are so close to each other, however it doesn't point to specific issue with the system.Sensation has been since unrelated back surgery in (b)(6) 2020.The rep was to follow-up with the hcp.

Event Description

Additional information was received from the rep and it was reported when the simulator is off the patient continues to feel burning.They determined with the tech on the phone that the burning is not related to the spinal cord stimulation.There was no external, environment, or patient factors that have contributed to this event.The cause of the burning was not determined.The burning did not resolve so the hcp and his nurse discussed prescribing lidocaine patch to relieve the burning.

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.

• 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: 10268023
• MDR Text Key: 198731222
• Report Number: 3004209178-2020-12085
• 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
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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: 03/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 73