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

Model Number	37601
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); High impedance (1291); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 in case the physician wanted to know about the battery consumption and calculate the battery longevity, the manufacturer representative (rep) got the session report, which showed the implantable neurostimulator (ins) was currently set to (b)(6) 2000.In addition, review of the session report showed there were high impedances on left subthalamic nucleus (stn) monopolar contact 1, bipolar contacts 0/1, and right stn monopolar contact 4.There was low impedance on left stn bipolar contacts 0/3 (191).There was no problem found about the programming affecting the patient.There was no fall or accident.They adjusted the implant date for accuracy.The issue was resolved.
Event or Problem Description
Additional information was received from the rep.The cause of impedance issues and timeline of the circuit problem was unable to be determined.The patient has a follow up with their provider in next 6 months.
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.
Additional Manufacturer Narrative
Additional review indicates that information from manufacturer¿s report #2182207-2025-00500 was already reported in this report (#30 04209178-2025-04315).Any additional information regarding this event will be submitted as a supplemental submission to this 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 physician inquired about an estimate on battery longevity for a dbs patient with an activa pc.The physician plans to schedule a patient appointment for follow-up.Longevity estimations of the implantable neurostimulator (ins) from implant and settings were provided: group a - 6 years until elective replacement indicator (eri) and 6.2 years until end of service (eos), group b - 7.3 years until eri and 7.5 years until eos, group c - 5.8 years until eri and 6.0 years until eos, and group d - 6.4 years until eri and 6.6 years until eos.It was also reviewed that the implant date of the ins was currently set to (b)(6) 2000 and to consider adjusting this to the accurate implant date.There were also some out of range impedance values (both high and low impedances) on several contacts (e.G.Contact 0, 1, 3, and 4), which likely indicated the presence of an intermittent integrity issue.It was recommended to avoid the electrodes that have out of range impedances as this might have consequences on battery longevity.The physician also inquired why it took so long as last battery life check on tuesday showed 2.83v with last battery replacement on 2017-dec-23.It was reviewed that the ins battery can last for months or years depending on the following factors: programmed parameters (amplitude, rate, pulse width, number of active electrodes used, number of programs per lead), system impedance, hours per day of stimulation, length of the implanted lead and extension, degree of patient control over programmable stimulation parameters.Additional information was received reporting that review of the session report showed there were high impedances on left subthalamic nucleus (stn) monopolar contact 1, bipolar contacts 0/1, and right stn monopolar contact 4.There was low impedance on left stn bipolar contacts 0/3 (191).There was no problem found about the programming affecting the patient.There was no fall or accident.They adjusted the implant date for accuracy.The issue was resolved.Additional information was received from the rep.The cause of impedance issues and timeline of the circuit problem was unable to be determined.The patient has a follow up with their provider in next 6 months.

• 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 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: 21561328
• Report Number: 3004209178-2025-04315
• Device Sequence Number: 21136243
• Product Code: MHY
• UDI-Device Identifier: 00643169100770
• UDI-Public: 00643169100770
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 03/20/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/18/2025; 04/01/2025
• Date Device Manufactured: 11/10/2017
• 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
• Patient Sex: Female