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	04/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.H3: product analysis found visually, the product was returned in a large plastic pouch.The product pouch was open from 3 of 4 sides of the pouch.There were traces of biological contamination at the distal end of the device (probe and tubing brass), and on the needle electrode.There were no signs of cracks or slits on vari-stim tube.There were scratches on a rotating index, and it was slightly difficult to rotate an index.Electrically, the specification for index positions shall be, index 0.5 = 0.5ma +/-.1ma (0.4ma ¿ 0.6ma), index 1.0 = 1.0ma +/-.2ma (0.8ma ¿ 1.2ma), and index 2.0 = 2.0ma +/-.4ma (1.6ma ¿ 2.4ma), and the actual reading was index 0.5 (0.4ma), index 1.0 (0.9ma), and index 2.0 (1.7ma), all within specification and light worked on all indexes.In the returned condition, there was no out of specification condition that was related to the complaint.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 the vari-stim did not work during surgery.Despite turning on the light, it did not generate stimulus.The procedure was completed with backup products.There was no patient impact.

• 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: 21466902
• Report Number: 9612501-2025-00539
• Device Sequence Number: 15658999
• Product Code: ETN
• UDI-Device Identifier: 00763000038311
• UDI-Public: 00763000038311
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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: 12/22/2023
• Device Model Number: 8562010
• Device Catalogue Number: 8562010
• Device Lot Number: 0223440947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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