MAUDE Adverse Event Report: MEDTRONIC XOMED INC. STIMULATING INCREMENTING PROBE; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	8225825X
Medical Device Problem Codes	False Negative Result (1225); Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during parotid case, the surgeon had a negative tone (tweedle) when touching a nerve.Physician expected to hear the positive ¿bump bump bump¿ biphasic wave sound indicating the nerve was being stimulated.Instead, the tweedle indicating that they were not touching nerve responded.Physician was confident he was on nerve.Older physician that was trained without the nim and very strong anatomy knowledge.Felt strongly that the system was incorrect.The procedure was extended for less than 1 hour.There was no patient impact.Event could not be replicated by rep or biomed.Used subsequently with different pi box and worked as expected.
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.

• Brand Name: STIMULATING INCREMENTING PROBE
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 19219366
• Report Number: 1045254-2024-00643
• Device Sequence Number: 8198535
• Product Code: GWF
• UDI-Device Identifier: 00763000112455
• UDI-Public: 00763000112455
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K934426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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 Model Number: 8225825X
• Device Catalogue Number: 8225825X
• Device Lot Number: 0225806066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/01/2024
• Date Device Manufactured: 01/14/2023
• 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