MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED

Model Number	37601
Medical Device Problem Codes	High impedance (1291); Migration or Expulsion of Device (1395); Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
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 lead; product id neu_unknown_lead (serial: unknown); product type: 0200-lead; implant date (b)(6) 2019.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
It was reported that the patient experienced high impedances on contact zero, over 4k ohms.The patient had a fall between the last visit in october and the recent visit, and during device interrogation, one of the leads was found to be out.There is concern about lead migration potentially affecting therapy, and one of the leads needs to be replaced.The patient is due for a battery replacement soon, and the doctor will investigate the high impedance during this procedure.Impedances were run at automatic and at 3 volts.
Event or Problem Description
Additional information was received from a manufacturer representative (rep).The rep reported that it was unknown if the fall was due to the device.After imaging was done, the surgeon saw that the right lead looked to have moved from initial implant.The battery depletion was confirmed to be normal based of the settings and usage.Cause of impedances was not determined.Surgery for the battery replacement is scheduled and they will investigate the impedance at that time.
Additional Manufacturer Narrative
D10: section d information references the main component of the system and other applicable components is the lead.Product id: 3389s-40, lot# va23s5z, implanted: (b)(6) 2019, product type: 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: neu_unknown, serial# unknown, product type unknown product id: 3389s-40, lot# va23s5z, implanted: (b)(6) 2019, explanted: (b)(6) 2025, product type 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received from a manufacturer representative (rep).The rep reported the procedure took place on (b)(6) 2025.
Additional Manufacturer Narrative
Continuation of d10: product id neu_unknown lot# product type unknown product id 3389s-40 lot# va23s5z implanted: (b)(6) 2019 explanted: (b)(6) 2025 product type 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.
Event or Problem Description
Additional information was received from a manufacturer representative (rep).Rep reported that system was explanted and discarded by hospital.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21915148
• Report Number: 3004209178-2025-07249
• Device Sequence Number: 19879709
• Product Code: MBX
• UDI-Device Identifier: 00763000175719
• UDI-Public: (01)00763000175719(17)210328
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/05/2025

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: 03/28/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 04/29/2025; 06/04/2025; 08/13/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/22/2025; 07/01/2025; 09/05/2025
• Date Device Manufactured: 10/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."; "SEE H11...."; "SEE H11...."; SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male