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

Model Number 97715

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Battery Problem (2885); Charging Problem (2892)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97745, serial#: (b)(4), product type: programmer, patient.Product id: 97745bp, serial#: (b)(4), product type: accessory.Product id: 97745bp, serial#: (b)(4), product type: accessory.Product id :97755, serial#: (b)(4), product type: recharger.Product id: 97755, serial#: (b)(4), product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).It was reported that the controller was charged to 100%, the connection was excellent, and the ins didn't charge after trying for 3 hours.The ins was at 70%.The ins was at 50% two days prior and they wore the controller for 2 hours with charging excellent, but the ins didn't charge.The patient hooked up the recharger and reported they had excellent recharge quality and the green light was blinking.No symptoms were reported.No further complications were reported or anticipated.Additional information received stated that the new recharge telemetry module did not fix the issue.The ins charge level was still not incrementing.Patient was issued a new controller.No symptoms were reported.There were no reported complications and no further complications were expected.It was reported that the recharger was received and the same issues continues.It was showing excellent recharge quality while charging the implantable neurostimulator (ins) but the battery would not increase after leaving it charging for 3.5 hours.A replacement controller was sent to the patient.There were no further complications or anticipations reported with this event.Additional information was received.It was reported the patient had received the recharger and then a controller but the problem was still happening.The patient stated the controller showed 100% charged but when they went to recharge the ins the screen showed battery was empty, recharge implant screen 81 or the screen would come up and state recharge excellent but the ins would never recharge and continued to show the red warning triangle.It was believed the recharger was at fault.A new recharger was requested.No further information was received.Additional information was received from the patient.Patient stated that she continues to have the same issue with recharging - patient repeated that she is sitting with the recharger on with excellent quality for 1.5 hours, but the ins charge level is not incrementing.Patient stated that her ins has shown it is off when she did not turn it off.It was suggested that the patient have the ins checked by an hcp/rep.Manufacturer representative (rep) said she would like to try lithium battery since patient is still having issue with recharging, that patient is getting excellent recharge quality, but the ins battery is not increasing.Rep mentioned that therapy is turning on and off.Rep said patient isn't willing to meet to troubleshoot.Caller was transferred to repair for a replacement battery pack.It was also reported that patient needed an mri of lumbar scan.Caller states the patient informed her that the ins battery is dead, and patient is waiting on receiving replacement equipment.Caller states, per patient, the ins battery died "3 weeks ago." caller noted that patient is seeing an hcp for pain management and has received injections.Caller was redirected to the healthcare provider (hcp) if the replacement equipment does not resolve the issue.

Event Description

Additional information was received from the patient.It was reported that on (b)(6) 2020, patient just received the form (patient letter) and had 4 different replacement parts since (b)(6).The whole trouble was the patient's internal battery not charging after 2-3 hours.For ins not charging and turning on and off, when patient was wearing the external charger, the patient was always standing doing kitchen work or sitting at the table doing different things because the she knew how very sensitive it was to movement.Every part was reissued to the patient donut antenna 2 times and external chargers and lastly external charger with new battery.With each new part it seemed to help for a while but then the problem still was unable to be completely resolved.Patient had not notified the managing healthcare professional (hcp) regarding this issue yet.The patient had talked to meeting with the manufacturer representative (rep) today.An appointment was scheduled last week but she was heading for vacation.Even with the new external battery charger that the patient received 2 weeks ago her internal charges still not charging.It was very disappointing and greatly aggravating.The internal battery was replaced (b)(6) 2019 and within 2 days, the donut antenna had to be replaced.Then, this (b)(6) 2020, one year later was when the patient started having all problems with no t being able to get charged internally.Patient service specialist (pss) and the patient got on speaker with the manufacturer technical specialist and tried troubleshooting small issues.Pss also reset 3 settings (a,b,c) with higher charger frequency so she could tell it was working and was told to turn stim off when she went to bed.

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: 10351485
• MDR Text Key: 201274772
• Report Number: 3004209178-2020-13243
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 90