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

Model Number 97715

Device Problems Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Headache (1880); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Sleep Dysfunction (2517); Electric Shock (2554)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who is implanted with a neurostimulator.It was reported that the patient has been trying to resolve problem since (b)(6) 2019, and nothing has been done to resolve the issue.It was reported that starting two years ago, approximately (b)(6) 2018, the patient started having sensations and strong pulses all the way up her neck, out her eyes and her head, which wakes her up in the middle of the night and causes a headache above her eyes and forehead.The patient alleged that it was caused by the stimulator.The patient spoke with her health care professional about the issue, and the health care professional dismissed the issue as being impossible and that it cannot happen.The patient also noted that she had been told by the health care professional that the wires are close to her spine and gravity pulls it down.The patient started turning it down at night and it was not as strong, but it was still waking her up.When the patient turned it to zero and off, she still feels the pulse that wakes her up.The patient indicated that it doesn¿t occur right when she first falls asleep, but rather two or three hours after she falls asleep, and that it happens when she rolls over on her left side.The patient never feels it unless she rolls over on her left side and that lying left is the worse.The patient indicated that her stimulator is on her right side.The patient indicated that she cannot sleep in any other position because she had her knee replaced.The patient noted that a clinician programmer was never used to check anything.The patient noted that they set the program back to the clinician settings which were used during the trial week and which was the most successful.The patient never notices the pulsations during the day.The patient wants the stimulation on during the day because she gets quite a bit of relief.The patient noted that she has not had any falls or trauma which may have caused or contributed to the issue.Additional information was received from the patient on (b)(6) 2020.It was reported that the patient's stimulation sensation around ins and up into head/ neck/ forehead and it wakes them up at night.Patient mentioned she had been working with doctor since last june and the rep did not help patient.Patient stated they were feeling stim go to the other side of body across from where the battery was implanted.Additional information was received from a manufacturer representative and a consumer regarding the patient on (b)(6) 2020.It as reported that the manufacturer representative met with the patient on the day of the report to interrogate the lead.The impedance measurement was normal and within range.The patient indicated that she was still experiencing the stimulation sensations even with stimulation to 0.0 milliamps.The manufacturer representative confirmed that the patient has not had any recent falls or trauma which may have contributed to the issue, so there were no abnormal circumstances leading to this change in stimulation.The manufacturer representative redirected the patient see her primary care physician who as the patient scheduled for an x-ray to determine if there was another issue of the lead; however, an issue with the lead has not yet been confirmed.The issue is not resolved yet.There were no further complications reported.

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 a nurse who call in to report that the patient stated at night, when they lie on their side they feel electrical pulsing sensation that travels up their body and behind their eye.They indicated that this sensation occurred even when the ins was turned off.The nurse reported that the patient had a hip replacement.It was noted that the patient was ¿high maintenance¿.

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

The patient reported that she didn't know the circumstances that led to the electrical pulsing sensation, apparently no one knows.The practice manager at texas back institute (tbi) called the customer service number and selected option 2.The answering person told her in great detail that the patient¿s symptoms, problem were impossible as when stimulation was turned off the connection was broken, disrupted, end of story.The patient had not had any resolution and tbi had washed hands of the whole situation.The only solution was to take it out.

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 re-reporting that it was unknown what led to the electrical pulsing.What they feel is a "programmed pulsing, a buzzing off and on, start, stop.They said this cannot be from, e.G, a pinched nerve." they talked with physicians and customer service and people at the medical facilities and were told it was impossible.The electrical pulsing was not resolved, and they were planning to visit a neurologist as soon as they could.

• 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: 10073213
• MDR Text Key: 191544187
• Report Number: 3004209178-2020-08839
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 61