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

Model Number	37601
Medical Device Problem Codes	Failure to Interrogate (1332); Energy Output Problem (1431); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a patient with an activa deep brain stimulation implant for ms tremor experienced ataxia side effects when the device was on and was unable to turn the device off after cooking on an induction stove, with the device remaining on for 24-48 hours before resetting.The patient programmer stopped connecting to the implantable pulse generator (ipg) during or after use of the induction stove, and the patient was only able to keep the device on for an hour at a time due to ataxia side effects, primarily using it for cooking.Device interrogation was performed and results appeared normal.Troubleshooting steps included having the patient use the remote away from the induction stove and turning off the communicator device immediately after use.The physician contacted engineers to investigate possible frequency interference between the induction stove and the communicator, and these steps were being tried as initial measures.No surgical intervention occurred or was planned.
Event or Problem Description
It was reported that the cause of the issue was due to the patient programmer communicator which stopped connecting to the implantable pulse generator (ipg) during or after use of the induction stove.Troubleshooting steps included having the patient use the remote away from the induction stove and turning off the communicator device immediately after use.It was unknown if the issue resolved.
Additional Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements stipulated in 21 cfr 803.Note that the h.6.Codes have been updated to reflect the new information.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 PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22849205
• Report Number: 2182207-2025-02142
• Device Sequence Number: 8458098
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: (01)00643169864191(17)200214
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 02/14/2020
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/08/2025
• Date Device Manufactured: 08/17/2018
• 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...."
• Patient Sex: Unknown