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); Delayed Charge Time (2586); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

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 who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that pt said they had an mri last thursday and put device into mri mode, then out of mri mode after the mri (pss asked if they also turned stim back on afterwards, pt said they did).Pt then said since friday night after the mri, they have noticed that the ins battery won't decrease from 100%.Patient services (pss) asked, pt said ins used to decrease ~50% in half a day, and pt had not had any changes in settings or usage at that point (pt mentioned keeps stim at 5.9).Pt also mentioned they have tried resetting controller (like rep jim had pt do when pt had a little issue a week or two after implant, pt didn't remember what the issue was) but ins still showed 100%.Pt then said they met with rep jim yesterday, and rep worked on pt's ins with their tablet, thought they had it fixed, however this morning the ins was still at 100% and when pt texted rep, rep told pt to call ps.Pt also said they went to try and charge ins last night, and ins was at 100% the whole time, and every 4-5 minutes a screen with a triangle and ! would come up, so pt would unplug rtm, plug back in and start recharging again (pss asked, pt did not remember anything else about the screen).Pss also asked, pt said they usually don't feel stimulation when it is on except for something in his right leg when charging, but rep turned intensity up temporarily yesterday to where pt could feel it to make sure stim was on.Pss had pt connect to ins with controller and pt reported controller battery 90%, ins 100%.Pt went to the home screen and reported stim was on with group a highlighted in green.Pt then started a recharge session and reported recharging excellent.At one point pt took rtm off and reported poor recharge quality (which pt said is what they saw yesterday and today with rtm over ins) but pt re-placed rtm and went back to excellent the rest of the time.Pss had pt reset controller and after reset pt said the ins battery was still at 100%.Pt went into program 1 on group a and said stim indicated it was on.Pt mentioned they saw on the screen stimulation is off, adaptivestim is on, but pt then went to the batteries screen and did not remember where they saw that, and could not find where they saw it during the call.Pss also had pt turn stim off and back on using top white on/off button.Pss reviewed to monitor battery levels after a bit of not charging and follow up with hcp/rep again.Pt mentioned they are nervous that they don't know the correct ins battery level as pt's pain was unbearable before they got ins.

Event Description

The patient reported that the circumstances that led to the implantable neurostimulator not depleting were unknown.No steps were taken to resolve the issue.The patient reported that after 5 days it started working again and the issue was resolved.

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: 11139653
• MDR Text Key: 225814992
• Report Number: 3004209178-2021-00397
• 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
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR