MAUDE Adverse Event Report: ALPHA OMEGA NEUROPROBE; ELECTRODE, DEPTH

Lot Number ELECTRODE CABLE: STR-000526-11

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194)

Event Type  Injury  

Event Description

During the micro-electrode recording the patient became dizzy, hyperventilated, and anesthesia reported hypo-tension.At this time the surgeon aborted the case and rushed the patient to a ct scan.The surgeon reported that there was no indication of any hemorrhage or declining health and the patient was going to be kept overnight for observation.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEUROPROBE
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): ALPHA OMEGA
• MDR Report Key: 17525370
• MDR Text Key: 321069083
• Report Number: MW5132311
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: ELECTRODE CABLE: STR-000526-11
• Patient Sequence Number: 1