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

Model Number	97725
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Itching Sensation (1943); Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 977d260 (serial: (b)(6)); product type: 0215-screening device; implant date: (b)(6) 2023; explant date: (b)(6) 2023, brand name surescan; product id: 977d260 (serial: (b)(6)); product type: 0215-screening device; implant date: (b)(6) 2023; explant date: (b)(6) 2023.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 or Problem Description
Information was received from a trial patient who was using an external neurostimulator (ens).Patient said she felt itchy when device was turned on.She also had increased pain in the middle of her back after procedure.Doctor said it could be possible hematoma.Patient also had blistering on back from the tape.Troubleshooting was performed. patient leads were looked at, which had moved from t8 to t9.Patient was reprogrammed from dtm to ld programming.Provider retaped back, noticed blistering, and dried blood on gauze.Patient was told that if it gets worse, or pain increases, to go to the hospital.Device were removed/ discarded.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17851463
• Report Number: 3007566237-2023-00021
• Device Sequence Number: 20540635
• Product Code: LGW
• UDI-Device Identifier: 00763000278762
• UDI-Public: 00763000278762
• Combination Product (Y/N): N
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2023

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: 02/18/2024
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/02/2023
• Date Device Manufactured: 08/18/2022
• 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...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female