MAUDE Adverse Event Report: UNKNOWN UNKNOWN LEADPOINT (LP) FOCUS; ELECTRODE, DEPTH

Device Problem Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that during the use of this device in the patient, the micro electrode recordings were extremely noisy.It was also reported that after extensive trial and error, it was concluded that the problem was due to malfunctioning of the lp focus.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN LEADPOINT (LP) FOCUS
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17536605
• MDR Text Key: 321184218
• Report Number: MW5143490
• 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: 01/08/2016

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