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

Model Number	8562010
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intra op, the vari-stim did not give a signal when the doctor touched a nerve. the procedure was completed with backup product. there is no patient impact.
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
H3: device was returned together with pli10 device in a double plastic sleeve (non-original packaging).Upon return, there were no traces of contamination observed on the device.It was observed that the rubber band was on the tube holding the electrode needle assembly.There was a clear cover on the probe tip while electrode needle was exposed when returned.When returned, the manifold indicator was at 2.0ma setting.The manifold was turned easily between each setting (0.5ma, 1ma, 2ma).Electrically, setting 0.5ma shall be 0.5 ± 0.1ma and the actual reading was 0.5ma; setting 1.0ma shall be 1.0 ± 0.2ma and the actual reading was 0.9ma; setting 2.0ma shall be 2.0 ± 0.4ma and the actual reading was 1.7ma, all readings were in specification.Furthermore, the led at the proximal end of the device illuminated a red light at each of the 3 settings as intended.There were no issues observed during the analysis of the returned device.The complaint was not confirmed, no out of specification condition was observed.H6: additional information suggest that b17, c20 and d16 longer apply to this event.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.

• 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: 23787726
• Report Number: 9612501-2025-03323
• Device Sequence Number: 18752584
• Product Code: ETN
• UDI-Device Identifier: 00763000038311
• UDI-Public: (01)00763000038311(17)270119(10)0230483457
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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 Model Number: 8562010
• Device Catalogue Number: 8562010
• Device Lot Number: 0230483457
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female