MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-12-26 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Burlington, Ma, Inc..
[3368510]
It was reported to integra "obejmann ocs2 usually generates too much current at the beginning or end of contract".
Patient Sequence No: 1, Text Type: D, B5
[10456634]
The device involved in the reported incident has not returned for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2012-00055 |
| MDR Report Key | 2917380 |
| Report Source | 05 |
| Date Received | 2012-12-26 |
| Date of Report | 2012-12-26 |
| Date Mfgr Received | 2012-12-06 |
| Date Added to Maude | 2013-03-26 |
| 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 | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer Phone | 6099365560 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OJEMAN CORTICAL STIMULATOR |
| Generic Name | NA |
| Product Code | GYC |
| Date Received | 2012-12-26 |
| Catalog Number | OCS2 |
| 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 BURLINGTON, MA, INC. |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-26 |