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

Model Number	8562010
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that intra-operatively, when the surgeon went to use the device it gave no stimulation to the patient and they were unable to stimulate any of the nerves they were targeting or others near by.The device was removed and the settings were adjusted on the end twice, and it still did not allow for stimulation.The issue was not resolved with repositioning or troubleshooting.New one was opened from same lot and expiry date which worked.There was no patient impact.
Additional Manufacturer Narrative
H3: product analysis found that visually, there a transparent plastic probe protector secured over the probe portion of the device, but a portion of the probe was bent when returned.Functionally, the probe sub-assembly/manifold turned between each of the current settings ¿ 0.5ma, 1ma, 2ma ¿ with no issues.Electrically, position 0.5ma shall be 0.5 ± 0.1ma and the actual measurement was 0.5ma; position 1.0ma shall be 1.0 ± 0.2ma and the actual measurement was 1.0ma; position 2.0ma shall be 2.0 ± 0.4ma and the actual measurement was 2.1ma ¿ all measurements were in specification.Additionally, the led, at the proximal end of the device, illuminated a red light at each of the 3 current settings as intended.There was no intermittent behavior while manipulating the tip, wire, or the probe sub-assembly.In the returned condition, there was no out of specification condition that was related to the complaint.H6: previously applied codes fdm b17, fdr c20 and fdc d16 are 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.

• 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: 20331013
• Report Number: 9612501-2024-02505
• Device Sequence Number: 9574130
• Product Code: ETN
• UDI-Device Identifier: 00763000038311
• UDI-Public: 00763000038311
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/11/2024

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: 07/04/2025
• Device Model Number: 8562010
• Device Catalogue Number: 8562010
• Device Lot Number: 0226902273
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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