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

Model Number 97725

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Unspecified Infection (1930); Pain (1994); Meningitis (2389)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977d260, serial#: (b)(4), implanted: (b)(6) 2020, product type: screening.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 05-oct-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported via a manufacturing representative (rep) that the patient had the spinal cord stimulation (scs) trial placed on monday (b)(6) 2020 with a planned removal on (b)(6) 2020.On the (b)(6) the patient spoke with the rep and he said he had a headache and neck pain and he was thinking of going to the hospital due to pain.I made his managing healthcare provider (hcp) aware.The rep called and left him a voicemail.On the (b)(6) the rep spoke to him and he said he was at the hospital, he had ¿an infection¿. per hcp-patient compliance, did not take antibiotic which may have led to the event. patient had high white blood cell count on labs and they are ¿presuming meningitis¿.  patient was admitted on iv antibiotic.The lead was discarded.It is unknown if the issue resolved.Additional information was received from the rep and it was reported that at this time, they were still unable to determine or confirm meningitis due to inability to access cerebral spinal fluid.They had performed lumbar punctures x3 and still no confirmation.They are ¿presuming meningitis¿ at this point.The patient remained in the hospital on iv antibiotic and pain management until further diagnosis/ intervention are confirmed.

Manufacturer Narrative

H10.Additional information related to regulatory report #2182207-2020-02999 will now be submitted under 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

Information was received from a patient, a manufacturer representative, and a health care professional.It was reported that the patient started a spinal cord stimulation trial with one lead on (b)(6) 2020 to address back pain.The patient also has pre-existing neck pain as well.On (b)(6) 2020, the patient started getting increased neck pain and a headache that was bad enough that the patient went to the hospital for care.The patient was seen at the hospital, but sent home.The patient went back to the hospital on (b)(6) 2020 and was hospitalized with a suspected infection.The manufacturer representative spoke with a nurse and the patient had an elevated white cell count and they were planning to do a lumbar puncture to determine the source of infection. the lead was still internalized, and the hospital did not want to take something out that they had not placed.The hospital was going to get a neurosurgeon involved to remove the lead.On (b)(6) 2020, they still had not done a lumbar puncture.The patient was still in the hospital as of (b)(6) 2020, and no lumbar puncture had been done, but the lead had been removed.The patient was diagnosed with presumed meningitis.The patient's physician who managed the trial noted that the patient did not take the prophylactic antibiotics that was prescribed during the trial period.

Manufacturer Narrative

Continuation of d10: product id 977d260, serial# (b)(6), product type: screening device.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 rep reported that the patient was ultimately discharged from the hospital and was seen in the office by a hcp on (b)(6) 2020.At that appointment, the patient told dr (b)(6) he ¿no longer had an infection.¿ it was never told to the rep from the (b)(6) team that this was confirmed as meningitis, after numerous calls made.The last person from (b)(6) that the rep spoke with was rn on (b)(6).He said at that time they had performed a 3rd lumbar puncture and it was still undetermined if it was positive for infection.The patient also did not know the source, only said that he had an infection.

Manufacturer Narrative

Continuation of d10: product id 977d260 lot# serial# (b)(6) product type screening device correction to notify date in initial report.Notify date should be 2020-11-24.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 NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10971122
• MDR Text Key: 220406580
• Report Number: 2182208-2020-03214
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000258115
• UDI-Public: 00763000258115
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2022
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention