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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); No Device Output (1435); Unable to Obtain Readings (1516); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97745, serial#: (b)(4), product type: programmer, patient.Initial reporter occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient's controller went haywire over the weekend.The patient explained that the language changed on the controller and the patient cannot read what is on the screen.The patient added the controller and battery levels suddenly went from 30% to 0 and now the controller battery is at 90% and the ins is "dead" because the ins needs to be charged.The patient was walked through changing the language back to english.The patient stated that they saw a screen 66, ins needs to be charged screen.The patient started a charging session and stated that the ins is charging.The patient couldn't read status as the device was in a different language still.The issues were all resolved though troubleshooting.No symptoms were reported.Additional information was received from a consumer.It was reported that the patient was unable to charge despite moving the antenna all over.The patient stated that the controller would say "finished", but the battery levels were only at 50% on the controller and 70% on the ins.The patent started a normal charging session during the call and was able to obtain excellent/good coupling.The patient was advised that the equipment was working as intended.The patient was going to finish charging and call back if necessary.The patient also mentioned that they could fell the "impulse" in their back, which was normal.No further complications were reported or anticipated.Additional information was received from the consumer on 2018-07-17.It was reported the patient could not get his ins to charge.The patient programmer was saying it could not find the position.He kept moving the insr around and got nothing.One time it flashed green and said no device found, try again.He kept pushing try and again and moved it around.The patient then reported that the controller has to be charged from the wall before he can complete the ins charge.The battery in the patient programmer will be dead before the ins recharges.It was reviewed that it is supposed to last for at least 1 session.The patient was advised to call back if he continued to have the same issue.During the call, the patient used the patient programmer and plugged in the insr.The patient programmer showed looking for device.The patient programmer then showed ¿no device found.¿ the patient programmer was reset by reinserting the lithium battery.The patient said he could not get the cover back on but would do it later.The patient programmer showed no device screen and then showed trying to recharge, #89 on low and #91 on high.The patient programmer shows checking for recharge quality and back to trying to recharge telling him to position insr and get the highest # and wait for 10 minutes.It was reviewed that the patient was getting this screen because his ins is depleted.The patient stated he knew the ins was dead.It had been on the charger for a couple of days and he forgot about it.He decided to charge again the day of the call.The patient said it was currently recharging.The patient further reported the ins was dead and therapy was not helping.It would show 50% charge of ins, but it did not make any difference, it did not seem like it was doing anything at all.It was more hassle than what it was worth.The patient mentioned he wishes he would not have gotten the device.The patient then said it seems when the ins goes completely dead he could tell the difference.Outside of that, he does not see any difference at all.The patient went to his follow-up appointment and the hcp said to try again.The patient had another appointment scheduled for the first part of next month.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the patient reported that their stimulation was off and they were unable to turn it back on.The patient turned stimulation back on and increased stimulation but they could not feel it.It was noted that the patient had met with the rep the day prior to the report and had their stimulation reprogrammed to hd settings.The rep had only 1 program on the ins.The patient reiterated that they did not think the ins was doing them any good.Since getting hd settings, the patient was having to charge twice a day.The patient wanted the ins taken out.The patient was advised to turn stimulation off until a potential appointment with their rep on 2018 (b)(6).No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received.Manufacturer representative reported the patient was reprogrammed using low dose stimulation.They were also retaught how and when to charge.The patient was charging their device when it reached 60 to 70 percent charge left.There were reportedly no plans for explant.No further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information from patient was received.Patient stated the ins was depleted and the ins turned itself off.Patient stated he tried to use the controller to turn on the stimulation, but the controller needed to be charged.Patient was wondering if the ins turned itself off.Patient was unable to turn stimulation on because the controller needed to be charged.It was noted the patient lost the battery cover of the controller.It was documented the controller was currently charging, patient would call back if he needed assistance to turn on the stimulation.Additional information was received from patient on 2018-august-20.Patient stated he received the replacement of controller and everything was working.Patient charged the ins from 30% to 100% and it took about an hour.Patient was wondering if that was normal.Patient services reviewed charging expectation.Patient stated the controller battery was at 100% when he started the charge session and went down to maybe 30% by the time the ins was full.It was stated the ins had been all the way depleted the controller battery might not have lasted enough to charge the ins to 100%.Patient services reviewed controller battery charged expectations.Patient repeated his concerned of therapy not helping as much as he wanted it to.It was noted he was not sure if it was worthwhile.Pss redirected to healthcare provider to coordinate.No further complications were reported/anticipated.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 professional (hcp).It was reported that on (b)(6), 2018, a mri technician requested mri guidelines for a lumbar scan.They reported the mri was unrelated to the device/therapy.When they tried to connect to the ins with the controller, the patient's controller would not communicate with the ins.The controller displayed "device not found".They tried multiple positions to try and get the controller to communicate prior to contacting technical services.The patient had told the hcp that their device "hasn't worked right" since they got it.The hcp reported that the patient was also not feeling therapy at the time of the call, but it was confirmed they didn't feel therapy because the patient's therapy was not on.It was reviewed that the ins may be discharged and advised to have the patient follow up with their doctor to have the device checked.No symptoms were reported.No further complications were reported or anticipated.

• 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: 7707777
• MDR Text Key: 115084760
• Report Number: 3004209178-2018-16330
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 95