MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-11 for AURAGEN GRID 8 X 8 CTS, 1 LEAD, 4 BRANCHES,SLITS AU8X8P14S manufactured by Integra Neuroscicencs Implants Sa.
[108035553]
The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[108035554]
It was reported that on (b)(6) 2018, an au8x8p14s auragen grid was used on a patient with prior brain surgery. The following day, it was discovered that the patient had a mild subdural bleed and the technicians reported that the grid was producing damp reading. The readings were okay to start with but over progression, the recordings became less and less until no recording were shown. It was also verified that since the location was in the brain, the bleeding was just normal and has nothing to do with the product. The main problem was the device not working properly. The following day, the patient was returned for surgery to remove the grid. No patient complications were reported and the patient's status post surgery was good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612007-2018-00010 |
| MDR Report Key | 7506877 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-11 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-07-02 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-05-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Street | 2905 ROUTE DES DOLINES |
| Manufacturer City | SOPHIA ANTIPOLIS F-06921 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | F-06921 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AURAGEN GRID 8 X 8 CTS, 1 LEAD, 4 BRANCHES,SLITS |
| Generic Name | AURAGEN GRID ELECTRODE |
| Product Code | GYC |
| Date Received | 2018-05-11 |
| Returned To Mfg | 2018-06-08 |
| Catalog Number | AU8X8P14S |
| Lot Number | 0204629 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Address | 2905 ROUTE DES DOLINES 2905 ROUTE DES DOLINES SOPHIA ANTIPOLIS F-06921 FR F-06921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-11 |