MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-03-11 for MICROTARGETING ELECTRODE FC2002 manufactured by Fhc, Inc,.
[40137878]
Product catalog number fc2002, microtargeting electrode, lot # 212327. Event date was (b)(6) 2016 at (b)(6). Event was described as follows: "during the first (left) side of the stage 1 there was satisfactory mer but then some unusual side effects (details unknown) experienced during the test stimulation. The neurologist and neurosurgeon decided to take a different trajectory. The second pass was 2mm anterolateral using the standard star drive array spacing. Mer was seemingly quiet down most of the tract. The neurologist decided to test stimulate at target but before any stimulation was delivered the neurologist decided to abandon the case due to the patient's condition and inability to speak. The fc2002 was removed and the neurosurgeon closed the burr hole and skin incision. The frame was removed and the patient had a ct scan, which showed a bleed in the basal ganglia region of the brain. The case was abandoned. 1-2 hours after the ct scan was performed it was reported that the patient was improving and was medically stable. " the electrode was discarded and thus will not be returned for analysis. Patient was improving and determined medically stable 1-2 hours after the ct scan was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002250546-2016-00001 |
| MDR Report Key | 5494583 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-03-11 |
| Date of Report | 2016-03-02 |
| Date of Event | 2016-02-12 |
| Date Mfgr Received | 2016-02-15 |
| Date Added to Maude | 2016-03-11 |
| 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 | ELECTRODE, DEPTH |
| Product Code | GZL |
| Date Received | 2016-03-11 |
| Model Number | FC2002 |
| Lot Number | 212327 |
| Device Expiration Date | 2018-03-15 |
| 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 | 2016-03-11 |