MAUDE Adverse Event Report: NATUS NEUROLOGY INCORPORATED NICOLET CORTICAL STIMULATOR

Model Number 982A0558

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2014

Event Type  malfunction  

Event Description

While performing an eeg exam using a nicolet cortical stimulator, the healthcare professional using the stimulator noted that the equipment reported an output stimulation level of "0" when stimulation was applied even though the equipment was set to deliver stimulation.A small level of stimulation was also noted as an eeg artifact although the level appeared low when compared to other equipment later used (once noticed, the healthcare professional switched to a different stimulation method).

Manufacturer Narrative

Registered internally as a complaint (b)(4) for further investigation by mfr.

• Brand Name: NICOLET CORTICAL STIMULATOR
• Type of Device: CORTICAL STIMULATOR
• Manufacturer (Section D): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view rd; middleton WI 53562 000
• Manufacturer Contact: randall moog ; 3150 pleasant view rd; middleton, WI 53562-0000 ; 6088298802
• MDR Report Key: 4213146
• MDR Text Key: 5152832
• Report Number: 3008289288-2014-00004
• Device Sequence Number: 1
• Product Code: GYC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 982A0558
• Device Catalogue Number: 982A0558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1