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); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Insufficient Information (3190); Data Problem (3196)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 04/25/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The manufacture representative reported that the patient¿s device stops continuously without the patient doing anything.It was noted that there was no pattern when it fails, it was always variable.There was one power on reset (por), on (b)(6) 2020.This por was related to a depleted ins, which means that on (b)(6) 2020, the patient has lost stimulation due to a depleted battery.Also on the (b)(6) the patient has lost stimulation due to a depleted battery.On the (b)(6) we see that mri mode was activated, which turns off the ins.The patient noticed that their stimulation was off because they felt more pain.When they used their patient programmer they would see that their green frame was gone around program a.No further complications were reported or anticipated.

Event Description

Additional information was received from the manufacturer representative reporting that the patient felt that his stimulation had gone out and when he looked at his remote control, the frame was gray stating "stimulation is off." the patient was not sure that this message appears every time his ¿dcs¿ has failed but asked that this be checked at a possible next time if this happens.Further stated that the ins turns on and off.The session report showed that the device was not registered.The patient started his ¿dcs¿ with the tablet to see if this made a difference, but here too he first got a shock and then gradually faded to the desired strength.The patient reported again that his ¿dcs¿ went out again when he got home.This time, the message ¿stimulation is off¿ was not on it.When the patient put the stimulation back on, this time the shock was even more intense than usual.Since the battery of the remote control was almost flat, it was still charging.It was noted that during the week of (b)(6) to (b)(6) the device was no longer on hd.Now the patient was back to hd.On (b)(6), the patient adjusted the control, and ate something in canteen.Suddenly the vibrations immediately stopped.The device was turned off when the patient got home.Around 10:30 pm the device was charging at 60%.The patient was going back to the nurse.The next day at 3 am watchman was off.Charging around 9:00 (unknown if this was am or pm) was still at 80%.The device was charged at 10:30 pm and was at 40%.(b)(6) the device was charged to 80% at 8:00 am.(b)(6) the device was charged 100% with band around body.Though around 21:00 the patient experienced a lot of pain on the left side.The device indicated that it was not in operation and the battery was at 80%.The mdt data showed device off caused by mri mode activated on (b)(6).The cause of the event was empty battery due to no regularity in charging.The action taken to resolve the event was reprogramming to reduce consumption.

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.

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 received reported that after device reprogramming from hd towards conventional, the patient was still complaining about sudden fall outs.He preferred hd to cover his pain.He¿s satisfied with the pain relief but is annoyed by the fall outs.Technical support couldn¿t find a devicefailure, based on several data reports.They even couldn¿t find a link between the data reports and the patient¿s diary with the registered fall outs.It was noted that they recently activated adaptive stim.The patient¿s device was replaced early.

Manufacturer Narrative

H6.Device analysis for ins (b)(4) revealed the ins was functionally okay.There were insignificant anomalies.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 MN 00777
• MDR Report Key: 10190851
• MDR Text Key: 199861641
• Report Number: 2182207-2020-00413
• Device Sequence Number: 1
• Product Code: LGW
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1