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); Unintended Collision (1429); Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Headache (1880); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Neuropathy (1983); Pain (1994); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Tingling (2171); Dizziness (2194); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Loss of consciousness (2418); Ambulation Difficulties (2544); Lethargy (2560); Alteration In Body Temperature (2682)

Event Date 11/20/2017

Event Type  Injury  

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 non-malignant pain.The patient reported that nothing seemed to be working when she turned it on and the battery on the inside had been off for the last week and a half.The patient also reported that she was feeling dizzy.No further complications were reported.

Manufacturer Narrative

Product id: 97745, serial# unknown, product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.They stated the controller connector does not work.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 a consumer regarding the patient.It was reported that the patient¿s device has not been working correctly for the last couple of months and that a manufacturer representative turned her device off almost two months prior to the report.The patient has had multiple medical issues because of the device being off.The patient had tried to connect to the implantable neurostimulator but was getting screen 15 (looking for a device).There were no further complications reported.

Event Description

Information was received from a consumer regarding a patient who is implanted with a neurostimulator for non-malignant pain.It was reported that the patient controller and recharger were stolen.The patient lost her balance and fell and landed on her back on (b)(6) 2018.Someone also landed on top of her.Since the fall, the patient has had an increase in pain in the back.The stimulation was giving her 70% pain reduction prior to the fall, and she was off all of her oral medications, and now the patient can barely walk.The patient has popping in her back due to spinal neuropathy.Since the fall, the patient is back on lyrica and tramdol.The patient¿s medical history includes two failed epidurals and a failed laminectomy and she was diagnosed with ¿falling back syndrome.¿ additional information was received from a consumer regarding the patient on 2019-mar-01.It was reported that starting about a week prior to the report, the patient was having difficulty charging the patient controller from the wall.The patient was out of the country and had the patient controller plugged into a wall outlet, and the patient controller came on for about 10 minutes one time, but now that she is back in the united states, the patient controller was not coming on at all.The patient was not able to charge the stimulation, and the stimulator had shut off, so she was not feeling well without the therapy since (b)(6) 2019.The patient had tried resetting the patient controller by taking out the battery pack and reinserting it, but this did not resolve the issue.The patient controller was also not coming on with aa batteries.The patient took the battery pack out of the patient controller and plugged the patient controller into the wall charger and the patient controller came on and showed the splash screen.The green light came on the wall charger, and the wall charger looked fine.Additional information was received from a consumer regarding the patient on (b)(6) 2019.Nothing seems to be working when the patient turns it on.The battery on the inside has been off for the last week and a half, and the patient was really dizzy.The patient requested to have a new patient controller sent overnight.The patient was sent a replacement patient controller on (b)(6) 2019.Additional information was received from a consumer regarding the patient on (b)(6) 2019.It was reported that the patient¿s device has not been working for some time.The implantable neurostimulator was not charging, and the patient controller constantly gives her an error message that she is not charging and tells her it cannot find the device and to put it closer to her body.The patient has not charged in a week, but the patient also noted that she has not been able to charge the implantable neurostimulator for almost two weeks.The patient has put the device over her implantable neurostimulator, and it is still not finding the device.While speaking with a patient service specialist, the patient used the patient controller.The patient controller was showing no device found.Instead of pressing try again, the patient pressed recharge, and then the patient controller showed screen 86 cannot recharge.Patient controller battery is too low.The patient plugged the patient controller into the wall, and it was showing green and looked like it was charging.After charging up the patient controller, it was still not connecting to the implantable neurostimulator.During troubleshooting, the patient was still seeing the no device found screen, so the patient started a passive recharge mode.The patient was able to connect and saw the green light blinking.After charging up the patient controller, it was still not connecting to the implantable neurostimulator.Additionally, it was reported that the patient¿s device will work for maybe a day or two, and then it will not work again.Starting in 2019 (for approximately two months), most of the days, the patient is not able to get out of her bed.Like on the day of the report, she felt very drained, with no energy, and like she is unable to do anything as it hurts her to go to work like this.The patient also reports feeling nausea.When the patient is not able to charge up, the patient¿s body feels a hot sensation around the implantable neurostimulator area.The patient is not able to get out of bed because she has no energy to get out of bed until she actually charges.It bothers the patient¿s feet.The patient would like to charge her implantable neurostimulator right now for the energy because her whole body is drained.She can feel herself ¿beeping¿ which was clarified to mean that the patient is feeling stimulation inside of her body.The patient was in the hospital because she was blanked out on (b)(6) 2019 and found unresponsive.It was noted that they had tried to help the patient but could not because of the implant.Additionally, the patient noted that this is giving her headaches.All of these issues started (b)(6) 2019.About two months prior to the report.Additional information was received from a consumer regarding the patient on (b)(6) 2019.This was the third time getting the equipment swapped out.The patient cannot successfully charge, and the patient controller was showing cannot find device.The patient has tried removing the battery pack and replacing it, and when she places the antenna over the implant, it says that it cannot find device.The patient controller was at 80% charge.The patient is able to get it to 100, but at the time of the call, the passive recharge was showing only 16.Touching try again caused it to look for the device, but after several attempts to reposition the antenna, the patient was unsuccessful.The implant battery was low and the icon was red.The stimulation stopped on (b)(6) 2019, and since then, she has not been feeling well, nauseated, and weak.The patient noted that whenever it is not charged, she feels weak.The patient said that she noticed that when she first got the stimulator, she could feel the difference when it was charged and when it was not charged.If it is charged, she has a lot of energy, and when it is not charged, she feels very, very different and nauseous to the point that it even hurts her eyes.The recharger would not locate the implant.The patient was sent a replacement recharger on (b)(6) 2019.Additional information was received from a consumer regarding the patient on (b)(6) 2019.Indicating that the patient has back pain and is throwing up.Additional information was received from a consumer regarding the patient on (b)(6) 2019.It was reported that the patient sent new battery pack due to it being lost.However, the battery pack was returned and analyzed with no anomaly.Not charging patient controller.Additional information was received from a consumer regarding the patient on (b)(6) 2019.The patient is having difficulty breathing and throwing up from her back pain and spasms.The patient¿s battery is completely dead.Additional information was received from a consumer regarding the patient on (b)(6) 2019.It was reported that the replacement stimulator (patient controller) needs to also be replaced.The connector does not work.Additional information was received from a consumerregarding the patient on (b)(6) 2019.It was reported that the stimulator for her back is no longer working.Additional information was received from a consumer regarding the patient on (b)(6) 2019.It was reported that the patient received the replacement patient controller.The replacement is still not working, and now the patient is in excruciating pain because the stimulation stopped on (b)(6) 2019.The patient was sexually assaulted on (b)(6) 2019.The patient was trying to recharge and was seeing the no device found screen.The patient kept on repositioning the antenna over the implantable neurostimulator and was able to get recharging excellent on the patient controller.The patient controller battery was at 80% charge and the implantable neurostimulator was in the red.The patient has been running into situations like this since (b)(6) 2019.Additional information was received from a consumer regarding the patient on (b)(6) 2019.It was reported that the patient stated that the issue is with the leads itself and the battery of the stimulator.The patient¿s physician is recommending that the patient stay at the hospital where she will have an mri done.The patient has pain in her leg.The patient was assaulted.The patient noted that she gets stuck in passive recharge mode when she attempts to recharge the implantable neurostimulator.In addition to the pain and nausea, the patient is experiencing headache and may be related to her spinal cord stimulation.The patient was redirected to continue troubleshooting with her physician.There were no further complications reported.

Manufacturer Narrative

Continuation of d11: product id 97745 lot# serial# nld036426n implanted: explanted: product type programmer, patient product id 9 77c165 lot# serial# va1km06019 implanted: (b)(6) 2017, explanted: product type lead product id 97745 lot# serial# nld015745n implanted: explanted: product type programmer, patient product id 97745bp lot# serial# nlh007221n implanted: explanted: product type accessory product id 97755 lot# serial# nlf012217n implanted: explanted: product type recharger h10.Additional information received regarding regulatory report #s 3004209178-2019-04678, 3004209178-2018-05502, and 3004209178-2019-10546 will be submitted as supplementals under this regulatory report if additional information is received.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: 8394200
• MDR Text Key: 137960468
• Report Number: 3004209178-2019-04581
• 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,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 08/02/2019; 08/02/2019; 09/24/2019
• Supplement Dates FDA Received: 08/16/2019; 08/29/2019; 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 48 YR