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); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Nerve Damage (1979)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the total thyroid for graves disease and goiter, started the procedure on left side lobectomy, nims tube for intubation and monitoring for procedure.Unit setup and tested at procedure beginning, and receiving feedback during beginning of procedure.Later in the procedure, the surgeon stated "nims was not working".At that time, it was on the monitoring screen, with no errors or messages, and providing no feedback.Restarted the unit and hardwired the patient interface with the unit.At this point it had intermittent "lost connection" messages.Connections were double checked and then moved to right side and all worked fine.At procedure end, surgeon stated complication of procedure was transected nerve.There was a blood loss about 500ml.The patient could swallow but his voice is breathy; upon follow-up the patient was hoarse, and voice had not recovered several days later.
Additional Manufacturer Narrative
Medical safety has reviewed the event.This event of reported no nerve response and it's subsequent reported harm and severity (nerve damage post-operatively, unknown recovery potential/status) are known and labeled per (b)(4) and ifu m987224a001.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: product analysis found that unit presented with no fault.H6: previouly applied fdm b18, b21, fdr c20 c21 and fdc d16 codes are no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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: 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: 19249239
• Report Number: 1045254-2024-00673
• Device Sequence Number: 7351484
• Product Code: GWF
• UDI-Device Identifier: 00763000112455
• UDI-Public: 00763000112455
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8225825X
• Device Catalogue Number: 8225825X
• Device Lot Number: 0226207807
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male