MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-29 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Burlington, Ma, Inc..
[134351364]
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
[134351365]
A sales representative reported on behalf of the customer that there was an issue with the ocs2 ojeman cortical stimulator on an unspecified date. Complementary information was received on 15jan2019 indicating that the product was in contact with the patient. It was reported that the patient was injured (negative mapping at 3ma on primary motor cortex procedure abandoned). The event did not increase surgery time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222895-2019-00001 |
| MDR Report Key | 8285283 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-29 |
| Date of Report | 2019-01-04 |
| Date Mfgr Received | 2019-03-26 |
| Device Manufacturer Date | 2012-05-13 |
| Date Added to Maude | 2019-01-29 |
| 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 BURLINGTON, MA, INC. |
| Manufacturer Street | 22 TERRY AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OJEMAN CORTICAL STIMULATOR |
| Generic Name | N/A |
| Product Code | GYC |
| Date Received | 2019-01-29 |
| Returned To Mfg | 2019-03-01 |
| Catalog Number | OCS2 |
| 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 BURLINGTON, MA, INC. |
| Manufacturer Address | 22 TERRY AVENUE 22 TERRY AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-29 |