MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Data Problem (3196)

Patient Problems Pain (1994); Shaking/Tremors (2515)

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 97745 lot# serial# (b)(4) implanted: explanted: product type programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was for the last 2 or 3 months randomly the pts stimulation would turn off without the pt turning the stimulation off, pt said they will no longer feel the tingling and when they check their controller, the stimulation was off.Then today 2 or 3 times while the pt was recharging their battery they have their programming set to group a and in the middle of charging the program switched to group b and the intensity would be increased almost to 16 for the intensity was at 15.6; normally the intensity is set to 8, 9, or 10 and they don't use group b or c for they use group a. at that high of intensity they got a lot of pain and their body was trembling for they had to decrease the intensity to 7 or 8; pts body was shaking and when the pt went to adjust their stimulation intensity it took 2 to 3 minutes to find the device to adjust their stimulation.Pt had reset the controller but that did not resolve the issue for report event reoccurred.An email was sent to the repair department to replace the 97745 controller.Pt said they never saw a pain specialist for their ins implant.Pt mentioned they had oxygen treatment in chamber.No symptoms or patient complications were reported.

Event Description

Additional information was received.It was reported that the circumstances that led to the stimulation turning off, switched programs and intensity was high was during recharge the patient noticed that the device had turned off.It was also noted that while they were recharging the system increased in intensity.The patient received a replacement device.The replacement device was working okay.

Manufacturer Narrative

Continuation of d10: product id 97745 lot# serial# (b)(6) implanted: explanted: product type programmer, patient 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.

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.

Event Description

Additional information was received from the patient (pt) via patient letter.Pt was 165 pounds at the time of the event.They do not know what cause the stimulation to go off, stated "it just happened".Patient was asked what steps was taken to resolved the issue and whether the issue had been resolved.Patient responded, "yes, i have a new device".This was understood as the replacement controller resolved the issue.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 12408332
• MDR Text Key: 271706926
• Report Number: 2182207-2021-01505
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 77