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

Model Number 97715

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient reported that when he lies down, he has been getting shocked despite having his intensity set at 5 milliamps.In the last two days, the patient decreased stimulation because if he coughed or sneezed, it hurt and he was getting shocked.The patient normally keeps the setting at 5.2 milliamps during the night and keeps therapy on.The patient noted that if therapy is higher, it hurts.The patient has not had any lifestyle change to cause the change in therapy.He turned stimulation down to 3 milliamps and has been turning stimulation off at night because he could not deal with the pain.The patient indicated that he takes medical marijuana for his pain.On the day prior to the report, he was feeling simulation when the therapy was off.He felt a zap when he coughed or sneezed on the night prior to the report.The patient also felt shocks in his sleep.He adjusted stimulation several times from 5 milliamps to 3 milliamps and then turned therapy off because he was not getting relief.The patient charged the implantable neurostimulator up to 50% on the night prior to the report, and in the morning, the implantable neurostimulator was at 40% charge despite having the therapy off.The patient noted that about 8 minutes after he checked his implant in the morning, the implantable neurostimulator was showing 10% charge.The patient also noted that for the last two weeks, he is struggling to keep his implantable neurostimulator charged and the implantable neurostimulator is not holding charges.He noted that he has to charge every 2-3 days.At the time of the report, the patient controller was showing that the implantable neurostimulator was low, the patient controller was at 50% charge, and stimulation was on group a at 3.0 milliamps.

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 met with his managing physician regarding the misfiring issue.Patient mentioned he hadn't seen his managing hcp in almost 3 yrs and there had been a couple car accidents he had been in that hcp was unaware of.Hcp ordered x-rays to see what could be causing the misfiring issue to ensure the device system was all intact.Patient said his arm hurt from having to hold it up so long because they did so much imaging at the hcp office.Patient said that he kidney stones and patient wondered if the kidney stones could be affecting the device in a way that was causing device to misfire and shock him.The patient's unrelated medical history includes kidney stones and neuropathy as well as medical marijuana use.Patient elaborated that by "misfiring issue " he meant that stimulator would misfire a shocking sensation, patient would feel stimulation stronger than it should be and this had caused issues with sleeping and getting the device to work the way he wanted it to work.Patient said stimulation misfired and shocked him in the testicle which had resulted in him accidently smacking his wife because he was startled awake in bed next to her.Patient said he will have another appointment with his hcp regarding misfiring issue once his x-rays were read.

• 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: 10595765
• MDR Text Key: 208917013
• Report Number: 3004209178-2020-16823
• 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
• Report Date: 04/14/2021

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: 04/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR