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 2018-05-22 for 6 CONTACT DEPTH ELECTRODE, 2.5 MM LENGTH, 5 MM SPACING AU6D5L25 manufactured by Integra Neuroscicencs Implants Sa.
[108901231]
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
[108901232]
An operating room manager reported that on (b)(6) 2018, the metal portion of the au6d5l 6 contact depth electrode came off and was left in the patient during a removal case. There was no patient injury reported caused by the event. Additional information received on 08may2018: the surgeon stated that the patient was notified of the retained items and that there should not be any further problems but the patient will be monitored for infection or further seizure activity. No further treatment was conducted to remove the electrodes. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612007-2018-00012 |
| MDR Report Key | 7533252 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-04-20 |
| Date Mfgr Received | 2018-06-01 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-05-22 |
| 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 | 6 CONTACT DEPTH ELECTRODE, 2.5 MM LENGTH, 5 MM SPACING |
| Generic Name | DEPTH ELECTRODES |
| Product Code | GYC |
| Date Received | 2018-05-22 |
| Catalog Number | AU6D5L25 |
| Lot Number | 0204991 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-05-22 |