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

Model Number	97725
Medical Device Problem Codes	Failure to Deliver Energy (1211); High impedance (1291)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); Insufficient Information (4580)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 977d260; serial# :(b)(4); implanted: (b)(6) 2020; explanted: (b)(6) 2020; product type: screening device.Product id: 977d260, serial#: (b)(4); implanted: (b)(6) 2020; explanted: (b)(6) 2020; product type: screening device.Product id: 977d260; serial#: (b)(4); implanted: (b)(6) 2020; explanted: (b)(6) 2020; product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 22-sep-2024, udi#: (b)(4); product id: 977d260, serial/lot #: (b)(4), ubd: 10-sep-2024, udi#: (b)(4); product id: 977d260, serial/lot #: (b)(4), ubd: 10-sep-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The manufacturing representative (rep) reported a spinal cord stimulation trial was performed on (b)(6) 2020.When one lead was placed in the epidural space, and connected to a wireless external neurostimulator (wens), stimulation was activated.The patient could feel no paresthesia.Impedances were checked, and were found to be all >10,000.Lead connectivity was good.First lead was explanted, and second lead was placed with the same results.An additional wens was tried, which produced the same results.The second lead was explanted, and a third lead was placed producing the same results.The trial was aborted, and the issue resolved.Physician requested that the product be returned for analysis.There were high impedances and no stimulation felt.There were no known environmental, or patient factors led to, or contributed to the event.
Additional Manufacturer Narrative
H3: analysis of product id 977d260 lot# serial#(b)(6), product id 977d260 lot# serial# (b)(6), product id 977d260 lot# serial# (b)(6) found no anomaly.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.
Additional Manufacturer Narrative
H3: analysis of the wireless external neurostimulator (serial number (b)(6) ) found that the batteries were depleted.When known good batteries were used the device functioned normally.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.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 10627205
• Report Number: 3007566237-2020-00375
• Device Sequence Number: 14104386
• Product Code: LGW
• UDI-Device Identifier: 00763000017590
• UDI-Public: 00763000017590
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2021
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 10/28/2020; 03/04/2021; 11/07/2024
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/02/2020; 03/07/2021; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."; "SEE H11...."
• Patient Sex: Male