MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-11 for NICOLET CORTICAL STIMULATOR 982A0558 manufactured by Natus Neurology Incorporated.
[5152832]
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
[12486567]
Registered internally as a complaint (b)(4) for further investigation by mfr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008289288-2014-00004 |
| MDR Report Key | 4213146 |
| Report Source | 05 |
| Date Received | 2014-09-11 |
| Date of Report | 2014-08-22 |
| Date of Event | 2014-08-22 |
| Date Mfgr Received | 2014-08-22 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2014-10-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RANDALL MOOG |
| Manufacturer Street | 3150 PLEASANT VIEW RD |
| Manufacturer City | MIDDLETON WI 535620000 |
| Manufacturer Country | US |
| Manufacturer Postal | 535620000 |
| Manufacturer Phone | 6088298802 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NICOLET CORTICAL STIMULATOR |
| Generic Name | CORTICAL STIMULATOR |
| Product Code | GYC |
| Date Received | 2014-09-11 |
| Model Number | 982A0558 |
| Catalog Number | 982A0558 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW RD MIDDLETON WI 53562000 US 53562 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-11 |