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
Event or Problem Description
It was reported that during procedure, (b)(4) units of the same batch did not operate successively.They continued the procedure without using the vari-stim.There was no patient involvement.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: (b)(6), product description: stimulator 8562010 vari-stim iii 10pk, lot #: 0228791746, ubd: (b)(6) 2026, udi#: (b)(4) h6: fdm b17, fdr c20, img g04102, and fdc d16 codes no longer applicable.Product id: (b)(6), product description: stimulator 8562010 vari-stim iii 10pk, lot #: 0228791746, ubd: (b)(6) 2026, udi#: (b)(4) h6: fdm b17, fdr c20, img g04102, and fdc d16 codes no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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
H3:four plis were returned together in large plastic sleeve (non-original packaging).Upon inspection, traces of contamination were observed on the tube.Under magnification, traces of contamination were also observed on the needle and probe tip.No damage was observed on the returned devices.At the time of return, the manifold indicator was set to 0.5 ma.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: 0.9 ma ¿ 2.0 ma (specification: 2.0 ± 0.4 ma); measured: 1.9 ma all electrical readings were within specification.Additionally, the led at the proximal end of the device illuminated red light at each of the three settings as intended.No issues were observed during the analysis of the returned devices.H6: fdm b17, fdr c20, and fdc d16 codes no longer applicable.H3: product:8562010, item:20,lotno:0228791746 - upon inspection, no damage was observed on the returned device.However, under magni fication, traces of contamination were observed on the needle and probe tip.At the time of return, the manifold indicator was set to 2.0 ma.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: 0.4 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 light at each of the three settings as intended.No issues were observed during the analysis of the returned devices.H6: product:8562010, item:20,lotno:0228791746 - fdm b17, fdr c20, and fdc d16 codes no longer applicable.H6: product:8562010, item:20,lotno:0228791746 - fdm b01, fdr c19, and fdc d1102 codes are applicable.H3: product:8562010, item:30,lotno:0228791746 - no damage was noted on the returned device.However, under magnification, traces of contamination were observed on the needle and probe tip.At the time of return, the manifold indicator was set to 1.0 ma.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: 0.4 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 light at each of the three settings as intended.No issues were observed during the analysis of the returned devices.H6: product:8562010, item:30,lotno:0228791746 - fdm b17, fdr c20, and fdc d16 codes no longer applicable.H6: product:8562010, item:30,lotno:0228791746 - fdm b01, fdr c19, and fdc d1102 codes are applicable.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 that user was not able to try to increasethe intensity of the stimulation to see if it changed something.

• 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: 24186141
• Report Number: 9612501-2026-00184
• Device Sequence Number: 9851202
• 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,Followup
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement 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