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

Model Number	8562010
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the device and an open pouch were returned in a plastic sleeve-non original packaging.The pouch was open from 3 of 4 sides when returned.There was an orange sponge covering the electrode needle and the distal end/probe wire.There was no damage noted in the construction of the device.However, the device was contaminated when returned.The manifold indicator was at 2.0ma setting upon return.The manifold turned 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 1.0ma; setting 2.0ma shall be 2.0 ± 0.4ma and the actual reading was 2.0ma, all readings were in specification.Additionally, the led, at the proximal end of the device, illuminated a red light at each of the 3 settings as intended.The complaint was not confirmed, no out of specification condition was observed.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 surgery, nerve stim worked for the first 5 mins of case then stopped.New stim was opened to complete the procedure.There was no patient impact in this event.

• 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: 22640028
• Report Number: 9612501-2025-02053
• Device Sequence Number: 9695426
• Product Code: ETN
• UDI-Device Identifier: 00763000038311
• UDI-Public: (01)00763000038311(17)250410(10)0226346155
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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: 04/10/2025
• Device Model Number: 8562010
• Device Catalogue Number: 8562010
• Device Lot Number: 0226346155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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
• Patient Sex: Unknown