MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. ACCURIAN; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	AC0010
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Neck Pain (2433); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
After doing one sensory test and then turning off sensory stimuli, there remained a pulsating stimuli that was observed with quivering of the patient's posterior neck musculature.Patient also endorsed feeling the high-frequency pulsation.From having experience with this unfortunately happening on rare occurrence previously, i had concerned that the medtronic needles may have bah some form of a defect.We initially replaced the probes to see if this would correct the issue, which it did not.At that time, again being familiar with the situation from a handful of times over several years, the needle cannulas were removed.New needles were then used.Sensory and motor testing was then conducted without any further technical issues such as previously seen and described above.- stated by physician [redacted].

• Brand Name: ACCURIAN
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 201 industrial way west; eatontown NJ 07724
• MDR Report Key: 25027904
• Report Number: 25027904
• Device Sequence Number: 10126463
• Product Code: GEI
• UDI-Device Identifier: 20763000153582
• UDI-Public: (01)20763000153582(17)290528(10)BY25E027
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2026
• Report Date (Section F): 04/08/2026

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: AC0010
• Device Lot Number: BY25E027
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 04/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/08/2026