MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-08-11 for 12 CONTACT DEPTH ELECTRODE, 2.5 MM LENGTH, 5 MM SPACING AU12D5L25 manufactured by Integra Neurosciences Implants S.a..
[16085927]
The product was used on an epilepsy pt and the depth electrode were implanted. The surgeon explained that he noticed blood in the tubing of the electrode immediately after implantation. The following day, the depth electrode with the blood in the tubing was not operating properly. They were able to localize the pt despite the defective electrode. There was no pt injury and delay in surgery. Additional inf was received from the customer on (b)(6) 2014 with the following. The depth electrodes were implanted and not working properly (with the blood in the tubing) on (b)(6) 2014. The user did not check the depth electrode intraoperatively if it initially worked after it was implanted. Pt age was not provided. The product problem was discovered in the neicu after the electrode was connected to the acquisition unit. The depth electrode "not working properly" was described as the contacts appeared to have flat lines and was not picking up any signal. Blood appeared to be seeping into the inner tubing of the electrode. The cable was switched out but it still did not work. The date of the resection was on (b)(6) 2014. There was no adverse pt consequence due to the defective electrode. The customer reported that had this electrode been working, "we would have had more info localize. This electrode was placed in the area of amygdala. The localization did not suffer as a result of this electrode not working as there were more electrodes in the vicinity. We were able to monitor from other electrodes in the area". The pt had a partial temporal lobectomy and hippocampectomy.
Patient Sequence No: 1, Text Type: D, B5
[16381655]
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 | 9612007-2014-00024 |
| MDR Report Key | 4001822 |
| Report Source | 05,06 |
| Date Received | 2014-08-11 |
| Date of Report | 2014-07-12 |
| Date of Event | 2014-07-11 |
| Date Mfgr Received | 2014-07-21 |
| Date Added to Maude | 2014-08-25 |
| 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 | 12 CONTACT DEPTH ELECTRODE, 2.5 MM LENGTH, 5 MM SPACING |
| Generic Name | DEPTH ELECTRODES |
| Product Code | GYC |
| Date Received | 2014-08-11 |
| Catalog Number | AU12D5L25 |
| Lot Number | 185795 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
| Manufacturer Address | SOPHIA ANTIPOLIS F-06921 FR F-06921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-11 |