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

Model Number	37601
Medical Device Problem Codes	Break (1069); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 3708660 lot# (b)(6) implanted: (b)(6) 2016 explanted: product type extension product id 3708660 lot# serial# (b)(6) implanted: (b)(6) 2016 explanted: product type extension section d information references the main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(6), ubd: 21-apr-2020, udi#: (b)(4) ; product id: 3708660, serial/lot #: (b)(6), ubd: 26-mar-2019, udi#: (b)(4).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 by the manufacturer representative (rep) that during the patient's replacement ins, they saw low impedance on the left side, 2-3 pairs.The rep requested assistance with amplitude conversion as the patient's ins was being replaced today; the current ins was depleted, so the rep only had electrode impedances.The caller provided the following settings: left side 2- 3+ 3.6 v, bipolar electrode impedance was marked as "do not use" and value of 227 ohms; right side 10- 11+ 3.5v, 1266 ohms.Troubleshooting was not required.The issue was not resolved through troubleshooting.Tss reviewed that 2-3 pairs were likely not providing therapy, and the pair shouldn't be programmed together, but the caller could consider programming c-2 (796 ohms) or c-3 (751 ohms).Tss provided estimated amplitudes for the left (if the caller used monopolar programming instead of 2-3 pairs) and right sides.The rep stated the patient plans to see a neurologist the next day.Additional information was received later: the rep said the hcp saw the left ext ension frayed. this was the first time the rep had heard about the impedance issue, and they were unsure when it started.The manufacturer representative (rep) provided additional information confirmed with the healthcare provider (hcp), indicating that it was unk nown whether any external factors may have led to or contributed to the issue.The battery was replaced due to normal depletion and was discarded.The extensions remained in the patient.The impedance issue was not resolved, and the patient was not using the contacts with impedance issues.
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 received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported it was unknown what led to the frayed extension.There were no actions planned to resolve the issue, but rather the hcp programmed around it.

• 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: 20318190
• Report Number: 3004209178-2024-19310
• Device Sequence Number: 8005266
• Product Code: MHY
• UDI-Device Identifier: 00763000384326
• UDI-Public: 00763000384326
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 01/28/2022
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/22/2024
• Date Device Manufactured: 08/13/2020
• 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 Sex: Male