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); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Device Overstimulation of Tissue (1991); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3998, lot#: v443435, implanted: (b)(6) 2011, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 3998, serial/lot #: (b)(4), ubd: 25-mar-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that information was received from a patient's representative regarding an implantable neurostimulator (ins).The reason for call was caller said the pt just recently had their ins replaced.Caller said they met with a rep today and had adaptive stimulation turned on (had pt walk, sit-up, laydown, and recline) and since it was turned on, the pt feels the stimulation turning off on them.Caller said if they turn a corner the stimulation will turn off, or hit a bump and it will cut on and be real high intensity, and will not keep up with the pt if they switch positions (patient services specialist confirmed the simulation will completely stop when they switch positions to certain positions).Caller said the rep checked the impedances of the leads and said they were fine.The patient was redirected to their healthcare provider to further address the issue.Pss reviewed how to change settings for adaptive stim and redirected them back to their rep to check the adaptive stim and cycling settings.The caller mentioned the pt's previous implant reaching eos and confirmed it was normal end of life (no allegations were made regarding previous ins).Redirected caller: patient's health care professional caller states the pt has ins replaced with new implantable neurostimulator due to normal circumstances.Caller states pt was initially set up by another clinical specialist in another area as far as programming goes.The pt wanted adaptive stim (as) and access to rate so the rep met with pt and set up as.Caller states the pt has low dose settings.Pt left the programming session happy with stim but on the way home the pt felt like when the car turned left or right he would lose stim sensation.The caller states pt alledges this as well at home when he turns his head left/right or up/down.Tss reviewed most likely a position was not given ma--caller states she told the pt to go through their positions and adjust with their controller.Caller did run impedances today and didn't provide any issues with impedances.Additional information received from a manufacturer representative.Caller reports she met patient at ins replacement.Caller reports patient did not have leads or extensions replacement.Caller reports there were no issue; coverage was good and no issue with impedance.Caller reports she spoke to patient today and will be seeing patient tuesday, may 4 for further assessment.Caller reports patient is getting good coverage, impedance still good.Caller reports when patient change position or move especially turning his neck or head, patient feels stimulation turning off and back on at a different setting and stronger stimulation, that caused patient to wet himself.Caller reports the leads are not cervical placement.Caller reports ins recognized right and left lying position, but laying flat sometimes do not recognized.Caller reports she advised patient to turn off as and do a diary.Additional information received from the manufacturer representative reported that all impedances were within 900-1450 ohm range.The adaptive stimulation was reoriented and set-up and after completely redoing the setup the adaptive stimulation seemed to be working fine.Unknown ¿cause¿ all impedance checks are normal.Adaptive stim has been re- programmed again with no issues.Patient still maintains that the phenomenon of the stim going to the point of him not feeling it, to surging strongly when he changes positions.He states that his surgeon told him before he went into surgery that he was replacing old lead with new sure scan lead as well a replacement of his ins.When he woke up post op, dr had only replaced ins.His pain dr is sending him back to the implanting surgeon.Patient's weight was unknown.Pain hcp was aware.Additional information was reported that the patient is still having issues with stimulation sensation turning on/off and patient dealing with surges, coupled with patient seeing the numbers change.Technical services (ts) had manufacturing representative (rep) compare the adaptivetism (as) overview to may 4th's number and there were a few positions that settings changed from 3.6 to 3.2 ma, but those changes were confirmed to have been made by patient.Patient reports that with as off, patient is still feeling stimulation turning on/off with neck movement.Impedance check showed 1-1580, 2-1600, 3-1630, 8-1650, 9-1650, 10-1640, 11-1640 ohms.Ts reviewed with rep that as is working as intended that system is not making changes since overview of as confirmed only changes were made by patient.Ts further reviewed that given patient is feeling stimulation on and off at random in random positions, it's likely a positional stimulation situation that makes it impossible for ts to advise any changes to the angles or transition settings.Discussed possible lead issue since this problem didn't start until after intellis was replaced.Additional information was received from a manufacturer representative (rep).It was reported that the cause of the reported issues was not determined and no additional actions would be taken at this time.The issue was not resolved.The patient's weight was unknown.Since this issue was first noticed, the patient has met with several manufacturer representatives and they said that reprogramming was done, but the patient says that it still does not work and is causing him some "bad problems." the patient noted that he had been told that "it was just in his mind," but the patient says that it is not in his mind.The patient has been trying to get these problems corrected since (b)(6) 2021.The patient was referred to another surgeon by his managing physician in (b)(6); however, the surgeon is not able to meet with the patient until august (b)(6) 2021.A manufacturer representative reported that the patient plans to have the lead explanted and replaced.They also want the implantable neurostimulator replaced because they feel that the device is faulty.The implantable neurostimulator and lead were replaced on (b)(6) 2021.

Manufacturer Narrative

Pli# 10 product id# 97715 and product id 3998, lot# v443435, implanted: (b)(6) 2011 explanted: (b)(6) 2021 product type lead found no significant anomaly.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
• 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: 12573577
• MDR Text Key: 276161999
• Report Number: 3004209178-2021-14808
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/24/2022
• Date Device Manufactured: 03/01/2021
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male