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

Model Number 37714

Device Problems Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Environmental Compatibility Problem (2929); Output Problem (3005); Insufficient Information (3190); Data Problem (3196)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Patient Problem/Medical Problem (2688)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

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 a patient who was implanted with a neurostimulator for spinal cord stimulator - nonmalignant pain/ failed back surgery syndrome.It was reported that the patient was having trouble with his stimulator.Caller stated patient was active/ working and his back was killing him, including when laying down so he ends up taking tylenol to help.Patient was set at 390 and turned it up, but it didn't seem to do any good.Caller noted the patient had trouble turning it up and that the setting would drop back down to a lower setting.Caller stated the patient waited 3 min while making the change.Caller stated the setting was 220, right leg.95 and left leg.50.Caller noted the same thing happened in the past.Patient was not available during the call; troubleshooting not possible.Patient redirected to healthcare provider.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 the had been wearing a heart monitor for their heart condition and that when the readings were all 'static.' this occurred at around the same time that the patient experienced the previously reported issues with their back and the change in settings.The patient clarified that their settings were too low to feel adequate therapy but that after waiting 3 min for adaptive stimulation to 'learn' the new setting, the issue resolved.The patient had not known that they had to wait 3 minutes for longer for adaptive stimulation.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that a few weeks ago they wanted to put a heart monitor on the patient and when the heart monitor was on, all of a sudden, all of the stimulating numbers dropped.The patient took the heart monitor off and gave it back to them after 24 hours and all they had was static on that.The patient said they didn't think it had anything to do with the stimulator, however, they had it at least 4 years and nothing had happened before.The patient stated it went from 4.90 on the middle of their back down to.05.The patient said it also works on each leg so they "are using 3 things on it".The patient said they went down to nothing or almost nothing and they had to finally set them back up again.The patient had to leave it for 3 something minutes but was told to try 4 or more minutes.The patient said it's working fine again and the heart monitor affected the stimulator.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 from the patient reporting that they wanted to know if being in high altitude could potentially cause their stimulator to use less battery.They stated that they were in the mountains for 10 days and usually charge their device every third day.They stated that they noticed the battery did not deplete much at all and so the charge was faster.They were wondering if being in high altitude could cause this.It was reviewed that high altitude shouldn¿t play a role and that the stimulator would still continue to run at the setting that they left it at.During the call the patient also mentioned this (b)(6) that they had a heart monitor and it turned their stimulation down causing them to have back pain.They stated they were worrying and just wanted to make sure their device was not going to do that again where their stimulation dropped down because it would give them back pain.The patient stated that their device had worked well for them.Patient services recommended that the patient continue to monitor if there are any changes since the patient just got home from the mountains yesterday evening.It was indicated that the issue of the stimulation dropping down due to the heart monitor began in (b)(6) of 2018 and it was asked but was unknown when the back pain began.No further complications were reported/anticipated.

Manufacturer Narrative

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 the patient.Patient noted that they were just getting around to responding to the inquiry that was sent in november of 2018.It was reported that the heart monitor that was in question at the time no, nothing's been done about that, it just shut down patient's stimulator.For example, patient's lower back was set at 4.90 and it went down to.05.Patient stated that their other question was in higher altitude, it doesn't need to be charged near as much; patient has experienced that before at 10k, 11k feet and there's not enough barometric pressure so it seems that any pain you have does not affect near as much at that elevation so patient has found out that they have had a lot of back surgeries and a foot surgery, whey get up in high altitude, it is not as painful because they tell patient it's because of the high altitude.The heart monitor definitely screwed up the stimulator really bad and shut the thing down almost to 0.The pain was excruciating so patient knows how much good this thing (device) really does and it is unbelievable because when patient is up and around during the day, patient has almost no pain.And of course at night time, it shuts down to about half way and get up in the morning, they are a little sore but it has been a real asset.No further complications were reported/anticipated.

• Brand Name: RESTORE SENSOR
• 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: 7756461
• MDR Text Key: 116897632
• Report Number: 3004209178-2018-17527
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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,Followup,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR