MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-04-11 for MICROTARGETING ELECTRODE FC1012 manufactured by Fhc, Inc,.
[72388875]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[72388876]
On (b)(6) 2017 - the reported device was used to position a lead of dbs system. During the procedure, the lead was inserted in the right brain and then the physician confirmed approximate 5mm inaccuracy from the targeted implant site. While the physician was considering re-insertion, the cerebral hemorrhage occurred. On (b)(6) 2017 the physician confirmed the recovery of intracerebral hemorrhage. On (b)(6) 2017 hematoma was surgically evacuated. Attending physician's comment: it is suggested that there were week and unrecognizable blood vessels and the cannula or electrode was possibly passed through the vessels. The device is used to insert a lead of dbs system. The physician mentioned a possibility that the hemorrhage may have occurred because the device touched the feeble vessels in the brain. The physician does not allege the device's malfunction. Although this event may be possibly caused by the procedure or the vessel condition of the patient, the device was not returned and the causal relationship between the event and the device is undetermined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002250546-2017-00003 |
| MDR Report Key | 6481040 |
| Report Source | FOREIGN |
| Date Received | 2017-04-11 |
| Date of Report | 2017-04-11 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-04-11 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2017-04-11 |
| Model Number | FC1012 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| 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 | 2017-04-11 |