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

Model Number 97715

Device Problems Intermittent Continuity (1121); Electromagnetic Interference (1194); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927)

Patient Problems Device Overstimulation of Tissue (1991); Insufficient Information (4580)

Event Date 11/20/2020

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 patient regarding an implantable neurostimulator (ins).The reason for call was patient had shoulder surgery last friday (unrelated to device) and since then he only feels his stimulation periodically (he verified that his stimulation was turned off during surgery).Pt said that he typically keeps his intensity at 3 and he has had to turn it up to 11 to feel it a "little bit".He said that he was having a "back problem" a couple of nights ago so he laid down and his stimulation felt very strong (his intensity was at 11).The patient was redirected to their healthcare provider (hcp) to further address the issue.Patient said that he doesn't plan on seeing his primary any longer.The patient mentioned that he had a mri of his shoulder a month ago (he verified that he put his ins in mri mode).The patient was redirected to the patient's hcp.

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 the patient.The patient stated he was still having issues.Last night he saw software problem, cannot recall any other icons.He reset the equipment many times and last night wanted to lower stimulation as stimulation was too high but he couldn't lower stimulation so he took out lithium battery pack.While on the phone, all was working at the moment.He stated the issue was he cannot control anything.He is down to 2.2 and still feels as though its at a 5v.Information was reviewed with patient that he could lower to 0 v in each group and see if that goes away as well as residual effect.He stated that he tried to turn down stim but it wouldn't and even resetting did not help.Patient redirect to their health care provider (hcp).He stated that both his ins and controller are both dying at the same time.He stated yesterday it was 100 and now it's 80.He stated on monday he went to the clinic and they did an x-ray and everything looked fine.He reiterated he had an mri a month ago and shoulder surgery 3 weeks ago.A replacement controller was sent to the patient.

Manufacturer Narrative

Continuation of d10: product id 97745 lot# serial# (b)(6) implanted: explanted: product type programmer, patient 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.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 received reported they were suffering from severe pain in their right shoulder.They were referred to an orthopedic surgeon where they ordered a mri of the right shoulder.The patient was diagnosed with right shoulder cuff tendinitis rubbing nerve per the healthcare professional (hcp).The hcp performed a surgery to correct the problem.The stimulator started acting up after the mri.After surgery, the stimulator worked and sometimes it didn't.Before the appointment, they had a x-ray to make sure leads had not moved and box was okay.All was okay.At the time, they were set up with two settings so if one went out, they had a back up.After the appointment, it said they had a software problem and shut down.They reset the box and it seemed okay for a while.When they went to bed, there was a surge and they had to shut it off.They reset it again in the morning and it worked for a while and then would not shut down.A new box was sent where they programmed the box and as of now the new box was working with no problems.

• 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: 10924487
• MDR Text Key: 219371942
• Report Number: 3004209178-2020-20829
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR