MAUDE Adverse Event Report: MEDTRONIC DOMINICANA DISPOSABLE NERVE STIMULATOR - VARI-STIM® III HAND-HELD; STIMULATOR, NERVE

Model Number	8562010
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: four plis were returned together in a large plastic sleeve (non-original packaging).Plis 10, 20, and 30 were complaint devices, while pli 40 was non-complaint; all returned plis were from the same lot number.Pli 40 contained six sealed pouches.Upon return, no damage was noted to the sealed pouches.One of the six sealed pouches was opened for analysis.No damage was observed on the device.The manifold was cycled through each setting (0.5 ma, 1.0 ma, and 2.0 ma), and electrical output was measured.The specified and measured values were as follows: 0.5 ma (specification: 0.5 ± 0.1 ma); measured: 0.5 ma ¿ 1.0 ma (specification: 1.0 ± 0.2 ma); measured: 1.0 ma 2.0 ma (specification: 2.0 ± 0.4 ma); measured: 2.0 ma all electrical readings were within specification.Additionally, the led at the proximal end of the device illuminated red at each of the three settings as intended.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 during procedure, 3 units of the same batch did not operate successively.They continued the procedure without using the vari-stim.There was no patient involvement.Additional information received that user was not able to try to increase the intensity of the stimulation to see if it changed some thing.

• Brand Name: DISPOSABLE NERVE STIMULATOR - VARI-STIM® III HAND-HELD
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 24892911
• Report Number: 9612501-2026-01080
• Device Sequence Number: 8998964
• Product Code: ETN
• UDI-Device Identifier: 00763000038311
• UDI-Public: (01)00763000038311(17)260509(10)0228791746
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K905035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 04/16/2026

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: 05/09/2026
• Device Model Number: 8562010
• Device Catalogue Number: 8562010
• Device Lot Number: 0228791746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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