MAUDE Adverse Event Report: NATUS NEUROLOGY, INCORPORATED NICOLET CORTICAL STIMULATOR

Model Number 982A0558

Device Problems Improper Device Output (2953); Output Problem (3005)

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

Event Date 08/22/2014

Event Type  malfunction  

Manufacturer Narrative

1) this is a re-filing of report 3008289288-2014-00004 with a new report number.The report was edited on (b)(6) 2015 to revise the facility registration number from (b)(4).The current facility registration number changed in may 2014 when natus neurology inc.Moved to its current location at (b)(4).Patient information was not provided, patient age and weight are therefore defaulted to "0".Device evaluated by manufacturer: device was not returned to manufacturer for evaluation.Registered internally as a complaint ((b)(4)) for further investigation by manufacturer.The internal investigation could not reproduce the problem condition reported nor did the complainant respond to further information requests.Subsequently, no other follow up actions were taken.

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).

• Brand Name: NICOLET CORTICAL STIMULATOR
• Type of Device: CORTICAL STIMULATOR
• Manufacturer (Section D): NATUS NEUROLOGY, INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer Contact: randall moog ; 3150 pleasant view road; middleton, WI 53562 ; 6088298802
• MDR Report Key: 5067052
• MDR Text Key: 26043195
• Report Number: 3010611950-2015-00017
• 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
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• 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: 07/20/2005
• 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
• Patient Outcome(s): Other