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

Model Number 97715

Device Problems Energy Output Problem (1431); Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Device Overstimulation of Tissue (1991); Complaint, Ill-Defined (2331)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient had experienced "something that is not a normal occurrence¿ which began at the end of (b)(6).They stated that the implantable neurostimulator (ins) was set up with adaptive stimulation (as) but whenever they were in a position like lying in a bed, on their back, upright in a chair, standing, they would suddenly experience a ¿stronger signal¿ that last approximately 30 to 40 seconds.The patient indicate that this strong signal came on in that position on its own and that the ins did that on its own after sitting in a position for 2-3 minutes.The strong signal would go away on its own.The patient noted that the controller was nowhere near them when the strong signal issue occurred.This strong signal issue was a ¿sudden change¿ that they patient had not felt before.It was reported that the patient had not had any falls but noted (as trauma) that they did swim 3 times a week (1/2 mile) and exercised.They also used a ¿she machine¿ where they lie down in a stirrup that cycles their legs and causes blood to slow to their spinal column.The patient had used this 1-2 times since being implanted with the ins.The patient stated that ¿what could have happen, is that before the implant he was able to improve (w/ swimming) his back's toleration and reduce his pain from a 8/10, to a 5 or 6 w/ swimming¿.Since the ins had been implanted, their pain was down to a level 3 which was ¿marvelous¿ and ¿made a big difference towards his life¿.They also reported that swimming might have helped improved their condition enough where the setting they had prior could have caused an improvement but they were unsure.Troubleshooting included review of the transition time set (which was something that would have to be changed by the physician as it was a programming scenario) and review of the soft start feature.The patient was encouraged to follow up with their healthcare professional (hcp).There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the patient on (b)(6) 2018.The patient stated that on (b)(6) 2018 they went to the spine center and asked to see the manufacture representative (rep) on duty.They did not see their physician because they had no complaint, but wanted to ask a few questions concerning the intensity settings of the stimulator programmer.Fortunately, the clinician who worked with their physician during the trial period and the implant programming was on duty and able to help the patient.The rep reprogrammed each of the body positions to intensity levels that they have found to be most comfortable.The rep did this on their computer and then transferred the settings to their programmer.The patient stated that it was difficult to answer if the issue was resolved because there was no identified cause or reason for the 30 second strong signal.Since the reprogramming there has been no reoccurrence.The patient is very pleased with their ins since the implant and it has successful reduced their chronic back pain from a 7-8 to a 2-3.This has been a major improvement to their life style.Beginning sometime on an unknown date in june they were standing and talking with their friend when suddenly they felt an increase in signal intensity that lasted about 30 seconds.Their adaptive upright setting was group a 8.6.The strong signal felt more like 10.6.When they were back home, they checked the setting and it was 8.6.Then about two weeks later on (b)(6) they were casually walking back from their mail box (a distance of approx.200 feet).They once again experienced a surge in intensity that lasted about 30 seconds.In both cases there were no apparent reasons or cause that they could identify.The stimulator has been performing beautifully since the implanting in february.The only possible variation to their usual physical habits was that beginning the last week in april they began swimming for exercise.Since then they have been comfortably freestyle swimming for a half mile three times a week without making any changes to the adaptive settings.No further complications were reported/are 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.

• 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: 7646043
• MDR Text Key: 112862943
• Report Number: 3004209178-2018-14558
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 67