MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-10 for NICOLET CORTICAL STIMULATOR 982A0558 manufactured by Natus Neurology, Incorporated.
[26043195]
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.
Patient Sequence No: 1, Text Type: N, H10
[26043196]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2015-00017 |
| MDR Report Key | 5067052 |
| Date Received | 2015-09-10 |
| Date of Report | 2014-08-22 |
| Date of Event | 2014-08-22 |
| Date Mfgr Received | 2014-08-22 |
| Device Manufacturer Date | 2005-07-20 |
| Date Added to Maude | 2015-09-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RANDALL MOOG |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6088298802 |
| Manufacturer G1 | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NICOLET CORTICAL STIMULATOR |
| Generic Name | CORTICAL STIMULATOR |
| Product Code | GYC |
| Date Received | 2015-09-10 |
| Model Number | 982A0558 |
| Catalog Number | 982A0558 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY, INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-10 |