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

Model Number 97715

Device Problems Intermittent Continuity (1121); Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Sleep Dysfunction (2517); Cognitive Changes (2551); Electric Shock (2554)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

Additional information regarding regulatory report # 3004209178-2021-04242 will be submitted as supplementals under this report.If information is provided in the future, a supplemental report will be issued.

Event Description

A manufacturer representative met with the patient on (b)(6) 2020 to turn on adaptivestim.The patient asked for a couple of new programs to try.The manufacturer representative gave the patient group b and c to try and adaptivestim was activated.At that time, the patient was satisfied with all three groups and denied any other complaints.The manufacturer representative got a call from the patient later that night saying that she could not turn stimulation off.The patient was walked through turning stimulation down.The patient had already had the settings at 0.0 volts.The patient seemed to be confused and noted that she was still feeling stimulation.The manufacturer representative walked the patient through how to turn stimulation off using the remote.The patient turned stimulation off and acknowledged that the patient programmer was showing that stimulation was off; however, the patient insisted that stimulation was not off and that she could still feel it.The patient was going to try troubleshooting with a family member.On (b)(6) 2020, the patient stated that the stimulation starts okay in the morning, but as the day goes on, it ramps up high and goes on full blast to the point that it is painful.The patient thought that the implantable neurostimulator was causing pain or that the stimulation was too high.The patient mentioned again that her stimulation was still on despite the implantable neurostimulator saying that it was off.The patient verbalized that the patient programmer said stimulation off.The patient met with the manufacturer representative and health care professional on (b)(6) 2020, and it was confirmed that the device was fully functional and there were no issues with the stimulation on or off.The cause of the overstimulation/painful stimulation and the inability to turn stimulation off was unknown.The patient needed re-education in how to work the system.The patient was reprogrammed, and re-educated on how to work the system.The issue was resolved.The patient reported on (b)(6) 2021 that she had a fall at the beginning of (b)(6) 2021, and following the fall, the patient was feeling the stimulation running/surging.The patient noted at that time that the stimulation wouldn't turn off.The patient noted that she was feeling suicidal pain that had been going on over a week.The patient had not slept all night.She was able to turn the implantable neurostimulator down to 0.0 volts and tried both groups a and b.The patient was finding that the pain is worse with stimulation on.She was in extreme pain and the stimulation was too strong.The patient was advised to turn stimulation down to 0.0 volts and to keep it off.Pt has been working with healthcare provider (hcp) and an xray was done on (b)(6) 2021 and showed that the ins and leads are all in place.The patient reported that the steps taken to resolve the stimulation issue and pain was that a manufacturer representative reset it, and now it is fine.However, it was also noted as "now big problem." it was noted that the stimulation issue and pain has been resolved; however, it surges and stops.The patient mentioned that she cannot get it to turn it off on full blast causing terrible pain.The patient noted that the device is faulty and she wishes that she never had it.She mentioned that she needs a new battery.

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

Information was received from a patient's representative regarding an implantable neurostimulator (ins).The reason for call was the pt now had a pump now for they did not have a stimulator anymore because one of the leads was on the nerve and was shocking them so they removed it.Pt said that occurred the year before last so maybe in (b)(6) 2021.

Manufacturer Narrative

Continuation of d10: product id 977a260, serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type lead product id 977a260, serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type lead.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
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 11668854
• MDR Text Key: 267159743
• Report Number: 3004209178-2021-06034
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 04/13/2021; 01/24/2023
• Supplement Dates FDA Received: 04/14/2021; 01/25/2023
• Date Device Manufactured: 06/02/2020
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female