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); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a manufacturer representative regarding a trial patient who was using an external neurostimulator (ens).It was reported that the patient contacted rep at 1:00 in the morning on sunday to state they had a tingling sensation throughout their body, from head to toe.Rep advised the patient to shut off the ens, however the patient reported they still had the sensation.Technical services (tss) advised rep to have the patient follow up with their healthcare provider (hcp).Tss transferred call to dbs cell.Dbs tss spoke with rep to discuss consideration of interference between both the scs trial wens and dbs.Reviewed to confirm dbs status as being on and if patient has tried to shut off dbs to see if whole body tingling goes away, as it hasn't yet with ens turned off.Tss reviewed that if dbs was the issue, still wouldn't expect the description of whole body tingling, but more of the return of tremors or dyskinesia.Rep indicated that patient reports that they need to pull themselves out of bed and patient was worried that they may have pulled the trial leads.Rep had redirected patient to er over the weekend and to managing hcps.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name lead; product id neu_unknown_lead (serial: unknown); product type: 0200-lead; implant date ; explant date brand name lead; product id neu_unknown_lead (serial: unknown); product type: 0200-lead; 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.
Additional Manufacturer Narrative
Continuation of d10: product id 977d260 lot# serial# (b)(6) implanted: explanted: product type screening device product id 977d260 lot# serial# (b)(6) implanted: explanted: 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.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.
Event or Problem Description
Additional information from the rep indicated that the implant date of the trial leads was (b)(6) 2024.They stated that no x-rays were taken, so they cannot rule in or out whether leads were dislodged/migrated.They stated that the cause of the tingling sensations were unknown.They stated that the device was shut off.Subsequently patient was unable to move and admitted to the hospital for 2 days.The rep stated that the tingling eventually stopped and patient regained ability to move and was discharged from hospital.

• 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: 19121120
• Report Number: 3007566237-2024-00012
• Device Sequence Number: 8230263
• Product Code: LGW
• UDI-Device Identifier: 00763000689469
• UDI-Public: 00763000689469
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 07/17/2025
• 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: 03/24/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/08/2024
• Date Device Manufactured: 02/07/2024
• 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 H11...."
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female