MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-09-24 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Burlington Ma, Inc..
[20975060]
At the receipt after repair, the device was found to be not working as expected. Stimulation stopped at 38 volts (high voltage is stated to be 40 volts or above). There would not be an insubstantial power being dissipated in the tissue around the probe (i. E. W=vi). There is no indication of a stimulation occurring when there most definitely stimulation occurring. This indication stops working at the higher currents. Product was not in contact with a patient, there was no patient injury or death alleged, and the event did not lead to an increase of surgery time. It was also reported that for use in-house, a current detection system was developed the customer for the osiris cortical stimulator as this had no indication of current at all. If this is used in parallel with the ojemann cortical stimulator then current can be detected even when the ojemann cortical stimulator stops detecting it.
Patient Sequence No: 1, Text Type: D, B5
[21299153]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2014-00025 |
| MDR Report Key | 4127868 |
| Report Source | 01,06 |
| Date Received | 2014-09-24 |
| Date of Report | 2014-09-05 |
| Date Mfgr Received | 2014-09-05 |
| Date Added to Maude | 2014-10-07 |
| 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 | OJEMAN CORTICAL STIMULATOR |
| Generic Name | NA |
| Product Code | GYC |
| Date Received | 2014-09-24 |
| Catalog Number | OCS2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-09-24 |