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

Model Number	97725
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Nausea (1970); Vomiting (2144); Chills (2191); Shaking/Tremors (2515)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 977d260, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 14-nov-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received via a manufacturer representative from a health care professional regarding a patient who started undergoing a trial of a spinal cord stimulation system on (b)(6) 2019.It was reported that the patient experienced nausea and vomiting, chills, and shaking during the spinal cord stimulation trial.The patient was placed on antibiotics during the trial.The impedance values were checked, and lead positioning was verified via x-ray.The health care professional repositioned the trial lead on (b)(6) 2019 as it appeared to have migrated.The health care professional questioned whether there was an allergic reaction to the lead when reporting the issue/complaint.The lead was explanted per patient request and discarded on (b)(6) 2019 to resolve the issue.There were no further complications reported.
Additional Manufacturer Narrative
Continuation of d10: product id 977d260, serial# (b)(6), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type screening device 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.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: 9611450
• Report Number: 3007566237-2020-00101
• Device Sequence Number: 14120577
• Product Code: LGW
• UDI-Device Identifier: 00763000017590
• UDI-Public: 00763000017590
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 03/29/2021
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 11/07/2024
• Date Device Manufactured: 10/22/2019
• 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...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 103 KG