MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problem Overheating of Device (1437)

Patient Problems Bruise/Contusion (1754); Unspecified Infection (1930); Burning Sensation (2146); Discomfort (2330); Fibrosis (3167)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Report source.Foreign: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (patient, manufacturer representative [rep], healthcare provider [hcp], foreign) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the rep was with a patient who had discomfort, bruising, and heat within the pocket when stimulation was on and off.This had been occurring for approximately two months.No falls or trauma was reported.No changes in stimulation sensation were reported.The patient reported the issue to the hcp who instructed the patient to ice the area, and to wear loose clothing and a lighter waistband.Last week the patient was told to turn off the stimulator.After turning stimulation off, the pocket appeared to reduce in color from bruising, but the warmth was still present.The ins pocket was assessed and the ins did not move around and appeared to be sitting in the pocket tightly.Pressure applied during recharging did not appear to be the cause, but was discussed.Due to the symptoms still occurring with stimulation off, possible infection, allergy, or twiddler's syndrome were discussed.The hcp did not believe the pocket looked infected or that it appeared like an allergy.The hcp would ask the patient to not recharge for another week then come back to the hcp office to assess the pocket again.At that time they may perform an x-ray.

Manufacturer Narrative

Please note, code f11 no longer applies to this report.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 hcp via the rep.It was reported that the patient has at the hospital on (b)(6)2021, and he had finished a course of antibiotics.The pain/discomfort was resolved, but the pocket wasn't really improving in terms of bruising and swelling.The patient had the ins turned off for over a month.The hcp was looking at explanting early the week of (b)(6)2021 while the patient maintains taking oral antibiotics.The implant date was provided.It was noted that the heat had also not resolved.They thought it may be infection.They thought the device would be explanted on (b)(6)2021 after further course of antibiotics.

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 hcp via the rep.It was reported that the patient was explanted on (b)(6)2021.His pocket post operative was still hard and fibrotic on palpation; however, incisions were healed and there were no signs or symptoms of infection.The patient had followed up weekly in the clinic until (b)(6)2021 and would follow-up at the patient's discretion as the situation demands.The patient did not require further spinal cord stimulation as they had increased function and mobility now without excessive pain.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 12017655
• MDR Text Key: 256752037
• Report Number: 2182207-2021-01066
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention