MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	37601
Medical Device Problem Codes	Break (1069); Low impedance (2285)
Health Effect - Clinical Codes	Shaking/Tremors (2515); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while the patient was getting another manufacturer dbs system replaced, they decided to get their other dbs system replaced as well.During the procedure device interrogation showed low impedances on the right side and additional testing showed the extension was malfunctioning, so it was replaced.The issue resolved without sequelae on (b)(6) 2025.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id: 3708660 (serial: (b)(6); product type: 0191-extension.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 3708660 lot# serial# (b)(6) implanted: (b)(6) 2019: product type extension 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: it was reported that results showed right electrode had high impedance at contact 9b and at multiple 9b intersections which suggested a damage extension.During surgery, it was determined the right extension was malfunctioning, and the right electrode was working just fine.In clinic, patient had resting, postural, and action tremor of the left upper extremity.Surgery was scheduled to replace the extension.It was also reported that the patient's tremors began to worsen and reprogramming improved them.The patient was then feeling worse since their appointment 2 weeks ago and had moderate side to side head tremors.Programming briefly helped but they continued to have tremors.A trend emerged where adjustments helped their dystonia but worsened their tremors.It became clear the patient needed a second system to help with therapy which was placed in 2024.After that the patients symptoms were controlled.
Additional Manufacturer Narrative
Continuation of d10: product id 3708660 serial# (b)(6) implanted: (b)(6) 2019 product type extension.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: it was reported that results showed right electrode had high impedance at contact 9b and at multiple 9b intersections which suggested a damage extension.During surgery, it was determined the right extension was malfunctioning, and the right electrode was working just fine.It was also reported that the patient's tremors began to worsen and reprogramming improved them.The patient was then feeling worse since their appointment 2 weeks ago and had moderate side to side head tremors.Programming briefly helped but they continued to have tremors.A trend emerged where adjustments helped their dystonia but worsened their tremors.It became clear the patient needed a second system to help with therapy which was placed in 2024.After that the patients symptoms were controlled.
Additional Manufacturer Narrative
Continuation of d10: product id: 3708660, serial# (b)(6), product type: extension.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 3708660 serial# (b)(6) implanted: (b)(6) 2019 product type extension product id b3300542m serial# (b)(6) product type lead.Additional review indicates this information was already reported in manufacturer¿s report #3004209178-2025-09632.Any additional information regarding the event will be submitted as a supplemental submission to that report.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 began noticing their ins moving in their left chest more freely about a month ago.They also developed chest pain and worsening of tremors.Left ins impedance check revealed high impedance on the right vim electrode at contact 9b and multiple intersections along 9b.This suggested extension damage so surgery was scheduled.In clinic, the patient had resting, postural, and action tremor of the left upper extremity.During surgery on (b)(6) 2025, it was determined the right extension was malfunctioning, and the right electrode was working just fine.Right extension was removed and replaced.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 22235288
• Report Number: 3004209178-2025-10330
• Device Sequence Number: 8176991
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: (01)00643169864191(17)200428(21)NKM767614H
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/22/2025

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: 04/28/2020
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 06/19/2025; 06/25/2025; 10/22/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 06/25/2025; 06/25/2025; 06/25/2025; 10/22/2025
• Date Device Manufactured: 11/12/2018
• 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...."; SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 66 KG