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

Model Number 97715

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c265, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977c265, serial/lot #: (b)(4), ubd: 18-feb-2025, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The manufacturer representative (rep) reported that on (b)(6) 2021, the patient was at their managing physician's office for a pump refill, and the nurse practitioner noticed that the incision site for the patient's spinal cord stimulator was oozing and red.The patient then saw their pain doctor the following day on (b)(6) 2021, and the doctor reported the site was infected.The patient was started on antibiotics and steroids, and the plan was to open the incision and wash it out well on (b)(6) of 2021.The physician hopes to save the implants.No device issues were reported.It was noted the patient had a history of infections following implant of their pump and following a brain surgery.

Manufacturer Narrative

Product id 977c265 lot# serial# (b)(6) implanted: (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.

Event Description

Additional information received from the manufacturer representative reported that the incision site for the lead was oozing while the pocket site looked fine.No cultures had been done.The patient had the incision washed out on (b)(6)2018, but still had to have it explanted on (b)(6)2021.

Manufacturer Narrative

Continuation of d10: product id 977c265, serial# (b)(6), implanted: (b)(6) 2021, explanted: 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.

Event Description

Additional information was received from the manufacturer representative (rep).The ins was explanted (b)(6) 2021.The stimulation was re implanted (b)(6) 2021.She is doing great.

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 reported that the patient's re-implant of her ins was scheduled for (b)(6) 2021.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12332212
• MDR Text Key: 266919374
• Report Number: 2182207-2021-01426
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/25/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 08/25/2021; 12/17/2021; 01/13/2022
• Supplement Dates FDA Received: 08/27/2021; 01/10/2022; 01/25/2022
• Date Device Manufactured: 05/15/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female