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); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Energy Output Problem (1431)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2020

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 manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that currently with a patient who reports his ins was turning off by itself.It was reported this happened 3 different times but the first two were explained to be normal behavior (after mri mode).The off incident occurred approximately 2 weeks ago per recharge session report the patient has never let the ins go to a discharge mode and typically recharges around 20-30% full.The recharge data available was for the past 6 weeks approximately.Rep was concerned the ins battery was not showing correctly on the controller, this was due to a previous reported incident and engineering was involved and discussed the controller ins charge level was inaccurate.Going forward patient will keep track of date/time the incident occurred so we can capture log files.

Event Description

Additional information was received from the manufacturer representative (rep).The cause of the ins turning off on it's own was not determined.The logs were checked and no explanation was round.The patient would log it and then they could match it up to the mdt file.

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.

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 manufacturer representative (rep) stating that the patient had therapy turned off 4 more times since he last called.Recharge data showed patient not going below 30%.The rep sent mdt file to allow decoding to investigate the cause.Per the mdt report, on (b)(6), the patient's stimulation was showed to be on , not as patient had reported.Also patient didn't recharge the day before the (b)(6) and the battery depleted within a day.It also indicated that patient charged (b)(6) and didn't recharge until (b)(6), when he was at 1 percent.Patient also reported the following; on (b)(6) 2020; the unit was found to be off when they tried to switch program to a program.Controller showing 30% internal ins.On (b)(6) 2020; patient found the unit off with a dead battery and on (b)(6), the battery was charged up to 100%.They manually charged the unit at approximately 1500 hours upon discovery of a dead battery.On (b)(6),patient found unit off, manually turned it on at approximately 1300 hours, and controller showing 30% internal ins.Patient manually turned the unit off as a pain response experiment (the only time i've done this), the unit was off from 0800 to 1600 hours on (b)(6) 2020.The settings were different than expected, on (b)(6), a-program adaptive set at 0.8 and on (b)(6).- a-program adaptive - set at 0.8 found at 0.4.

• 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: 10278053
• MDR Text Key: 198947743
• Report Number: 3004209178-2020-12245
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR