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 Deliver Energy (1211); Low impedance (2285); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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 pc implantable pulse generator presented to the hospital with off stimulation, and a charge density exceed warning was identified.When an impedance test was performed at 3v, there was no therapy impedance result because the implantable pulse generator was off.An impedance test at 0.7v produced a therapy impedance result, allowing determination of the true charge density threshold.Low impedances were discovered on contacts 2 and 8, which were avoided.Technical service was consulted.The issue was not resolved at the time of this report.No surgical intervention occurred or was planned.No patient complications have been reported as a result of this event.
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
Additional information was received from the rep.The issue has not resolved.Patient's stimulation being off was a result of them operating their patient programmer to manually turn it off.At patient's next visit, rep plans to recheck impedance with 3v and avoid electrodes 2 and 8.Additional information was received from the rep.The reason for avoiding contacts 2 and 8 was due to low impedances (below 300 ohms for contact 2 and around 400¿500 ohms for contact 8).Additional information was received: it was reported that the patient went to the clinic.The electrode impedances were checked with 3v and all impedances were in the normal range, but impedances of electrode 2 and 8 were quite low.The electrode impedance of electrode 2 was 283 ohm.The electrode impedance of electrode 8 was 435 ohm.Regarding to the technical service¿s advice, physician decided to reprogram by avoiding electrode 2 and 8.The curr ent settings were electrode 3 and 11.Patient had good clinical outcome.The issue was resolved.The physician also advised them to turn off stimulation during the daytime.

• 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: 22854819
• Report Number: 3004209178-2025-14186
• Device Sequence Number: 4461679
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: (01)00643169864191(17)191128
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: 11/28/2019
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/17/2025
• Date Device Manufactured: 05/31/2018
• 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: Male