MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-11-27 for MICROTARGETING ELECTRODE FC2001 manufactured by Fhc, Inc,.
[60907104]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[60907105]
Product used: fc2001, lot # 221236 - microtargeting electrode. During the use of the microtargeting electrode on (b)(6) 2016, the patient had a cerebral hemorrhage. Event was described as follows: after a lead was positioned in the right side, miniature potential in the left side was measured. Multi-technique method was conducted, and 2 tracks of center and postero were recorded. Waves could not be confirmed at depth of stn target (stn waves seemed to appear partly but were unstable). Sn waves seemed to be identified at plus 1. 5mm to 5 mm on the postero side. Tracks were changed to latte and antelo to measure again. Although impedance declined at 1200 ohms on latte side and around 700 ohms on antelo side, the procedure was continued. At re-measurement, even small typical background waves were identified. The patient experienced motor function and consciousness level in depression on the left side of the body. The procedure was aborted. Ct scan images identified cerebral hemorrhage. The patient was placed under monitoring the customer did not consider that the reported product caused the event issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002250546-2016-00003 |
| MDR Report Key | 6128176 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-11-27 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-10-27 |
| Date Mfgr Received | 2016-10-31 |
| Date Added to Maude | 2016-11-27 |
| 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 | MR. CRAIG PAGAN |
| Manufacturer Street | 1201 MAIN STREET |
| Manufacturer City | BOWDOIN ME 04287 |
| Manufacturer Country | US |
| Manufacturer Postal | 04287 |
| Manufacturer Phone | 2076665651 |
| Manufacturer G1 | FHC, INC, |
| Manufacturer Street | 1201 MAIN STREET |
| Manufacturer City | BOWDOIN ME 04287 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 04287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROTARGETING ELECTRODE |
| Generic Name | DEPTH ELECTRODE |
| Product Code | GZL |
| Date Received | 2016-11-27 |
| Model Number | FC2001 |
| Lot Number | 221236 |
| Device Expiration Date | 2019-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FHC, INC, |
| Manufacturer Address | 1201 MAIN STREET BOWDOIN ME 04287 US 04287 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-11-27 |