MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-04-21 for AURAGEN STRIP 6 CTS AU1X6P manufactured by Integra Neurosciences Implants S.a..
[16549986]
It was reported that the strip electrode did not work. There was no pt injury and no delay in surgery. Additional info was requested and on (b)(6) 2014, the following was provided by the sales rep: (b)(6) year old male pt with an underlying med condition of a brain tumor underwent a craniotomy. The electrode was put in to the monitor, reading depression postoperatively; the electrode was not working. It was unk which of the 6 contacts did not work. The strip electrode was taken out of the pt in the intensive care unit (icu). They did not put in another one even though there were other strip electrodes available to be used. They did not monitor the pt when the strip electrode was not working correctly. Pt outcome was unk. The lot number of the product was also unk.
Patient Sequence No: 1, Text Type: D, B5
[16688369]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612007-2014-00013 |
| MDR Report Key | 3855706 |
| Report Source | 07 |
| Date Received | 2014-04-21 |
| Date of Report | 2014-04-01 |
| Date of Event | 2014-03-15 |
| Date Mfgr Received | 2014-04-01 |
| Date Added to Maude | 2014-06-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AURAGEN STRIP 6 CTS |
| Generic Name | AURAGEN STRIP ELECTRODE |
| Product Code | GYC |
| Date Received | 2014-04-21 |
| Catalog Number | AU1X6P |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
| Manufacturer Address | SOPHIA ANTIPOLIS F-06921 F-06921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-21 |