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

Model Number	37612
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that information was received from a patient¿s representative stating the patient was experiencing shaking on both s ides and that when attempting to check therapy with the patient programmer, an unfamiliar screen was displayed despite replacing the programmer batteries multiple times.The representative reported that the symptoms began several days earlier.The caller described seeing an over-discharged screen.Pss reviewed the message's meaning.During the call, the patient representative connected the implanted neurostimulator to the wireless recharger and observed that charging was occurring on one side.The agent reviewed for the patient to continue charging.The patient's representative called back for assistance to turn the patient's (pt) therapy back on.The caller said they tried to charge, the stimulators would charge for a few seconds, then make the fully charged tones.The caller used the programmer to check both implants and confirmed that the left-side ins displayed a low-battery screen with therapy off, which was successfully turned on, while the right-side ins continued to display an over-discharged screen.The representative was advised to continue charging the left ins, which had resumed therapy, and to call back after a while for assistance to try to resolve the charging issue for a few seconds, then make the fully charged tones.Recharging guidance and reference materials for the programmer and wireless recharger were provided.Additional information was provided on june 01, indicating that the patient representative reported ongoing charging issues with the right ins, which continues to display a low battery despite daily recharging.The caller checked the right ins with the patient programmer and confirmed a low-battery message.The caller said the patient typically recharges themselves until they hear the tones; however, the caller wasn't familiar with the tones.During troubleshooting, a recharge session was initiated, and the recharger produced two descending tones accompanied by an orange indicator light, which the patient confirmed ha d previously occurred.The recharger was reset, and charging was attempted on both sides.The left side was shown as low.The caller then placed the recharger over the left ins and started a recharge session.The recharger stayed on for longer; however, they then heard the same descending tones and the orange light.The agent reviewed the initial call because it mentioned an over-discharge screen.When asked, the caller confirmed that the implant hadn't been recharged for an extended period but was unable to provide any specific details.The agent reviewed potential over-discharge; however, that would affect the ability to recharge implants.The agent decided that the patient received an orange light on the recharger when attempting to recharge each side, even though the recharger was showing as fully charged, and replaced the recharger as a troubleshooting step.The caller confirmed that they only have the patient programmer and that they dont have a handset.The caller was advised that if charging remains unsuccessful with the replacement device, the implant batteries should be evaluated by the managing healthcare provider.The caller reported the patient had recently been seen by a physician assistant and is scheduled to see a neurologist on august 3.The caller will provide updates after further follow-up.The patient provided additional information indicating that the left-side issue was likely due to not charging the device long enough and to misinterpreting the recharge tone, which led the patient to believe the device was fully charged.The patient reported that the right-side system has no issues.The patient representative reported additional information indicating that they received a replacement recharger but accidentally returned the replacement and retained the non-working unit.Troubleshooting of the non-working recharger was performed during the call, including resetting it while in and out of the dock, but the issue persisted.A request was sent to repair services to provide another replacement recharger.The caller also reported that the patient has been experiencing worsening shaking over the past couple of weeks.
Additional Manufacturer Narrative
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.

• 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: 25481316
• Report Number: 3004209178-2026-09918
• Device Sequence Number: 15944104
• Product Code: MHY
• UDI-Device Identifier: 00763000100360
• UDI-Public: (01)00763000100360(17)210528
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: 05/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 06/26/2026
• Date Device Manufactured: 07/10/2020
• 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...."
• Patient Age: 79 YR
• Patient Sex: Female