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

Model Number 97715

Device Problems Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892); Operating System Becomes Nonfunctional (2996)

Patient Problems Burn(s) (1757); Distress (2329); Insufficient Information (4580)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Product id 97755 lot# serial# (b)(4) implanted: explanted: product type recharger.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), ubd: , udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) regarding an external device.The reason for call was patient reported controller died last night ((b)(6) 2021), black screen while charging the implant, controller will not function.The patient was asked to reset the controller and look for damage inside the controller and battery pack and patient said there is no damage on the battery pack or controller.The patient was asked to plug controller into the outlet and patient said he is in a car and did not have the ac power supply.The patient was asked to place the battery back into the controller and controller powered on.Controller screen showed ins 20% and controller needs to charge.Patient mentioned the controller was at 100% last night when he started charging the implant and controller went to 90% and screen went black.The troubleshooting steps that were taken on the call resolved the issue.Reviewed rechargeable and non-rechargeable batteries.Reviewed charging up controller and charging the implant and if the issue continues or any messages on the screen call in for assistance.No patient symptoms reported.Additional information was received.The patient (pt) called back on (b)(6) 2021 and reported that since the beginning of february (pt then said in the last 4 months) the device had become a "total bust." pt said their controller would shut down and quit when recharging and their controller would not hold a charge.Pt said when recharging the implant they would go from charging implant to not charging implant without moving.For the past few months the recharging process had been acerbating for the pt.On sunday ((b)(6) 2021) when recharging the implant the recharger (rtm) became so hot it was burning the skin on their side (when asked, the pt did not verify if it was a burning sensation or if there was a mark left).Pt stated the controller got very hot as well for the controller was extremely hot but not nearly as hot as the rtm for the rtm was unbelievable.Pt said they weighed the same as when implanted and the device had become more of an inconvenience for it was frustrating.Pt said the controller would deplete faster as well for the controller battery would deplete from 100% to 85% or 90% after an hour and after days the controller would deplete from100% to 70%.During the same time as the event date the pt noticed that their implanted device needed to be charged more frequently.They used to charge their implant every 5 days but now they charge every 2 or 3 days.Pt said they have not changed the levels but they are active and do increase levels (pt said they have increased t heir stimulation intensity for they're active).An email was sent to the repair department to replace the rtm.Pt said their healthcare provider (hcp) did the last implant replacement, no allegations were made about the device regarding this.

Event Description

Additional information was received.It was reported the circumstances that led to the recharger burning and frequent recharging was an increase in activity and change to device programming.The patient requested a replacement recharger and the issue was resolved.

Manufacturer Narrative

Continuation of d10: product id: 97755, serial# (b)(6), product type: recharger, product id: 97745, serial# (b)(6), 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

H3: product id 97755, serial# (b)(6), was returned for product analysis.Analysis found there was a recharger telemetry module (rtm) failure, the no device found message was seen and the device was scrapped after failing at plexus and bench testing.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

See h10.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• MDR Report Key: 12138300
• MDR Text Key: 262451669
• Report Number: 3004209178-2021-10557
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 61 YR
• Patient Weight: 87