MAUDE Adverse Event Report: FHC, INC. MICROELECTRODE RECORDING PRODUCT; ELECTRODE, DEPTH

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A medtronic employee reported that a customer informed them that they had a bad electrode on an fhc microelectrode recording product.An e-mail was sent to fch at quality@fh-co.Com on 4/18/2013 to inform them of this reported complaint.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MICROELECTRODE RECORDING PRODUCT
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): FHC, INC.
• MDR Report Key: 17533377
• MDR Text Key: 321198101
• Report Number: MW5140281
• 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: 10/07/2013

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1