MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-16 for MICRO TARGETNING ELECTRODE - DZAP 34685Z manufactured by Fhc, Inc..
[29010167]
User facility discarded device. Not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[29010168]
Patient was scheduled to be implanted for a left vim dbs electrode. During microelectrode recording, the patient experienced bradycardia and became difficult to arouse. The procedure was aborted. The surgeon suspected the patient suffered a hemorrhage. Fhc micro targeting dzap electrodes were used in the procedure. The patient had an infarct along the tract during the second mer pass. The patient made good gains post-op and is in the inpatient rehabilitation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005677147-2015-00003 |
| MDR Report Key | 5168084 |
| Date Received | 2015-10-16 |
| Date of Report | 2015-10-14 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2015-09-14 |
| Date Added to Maude | 2015-10-22 |
| 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. FREAD HAER |
| Manufacturer Street | 1201 MAIN ST |
| Manufacturer City | BOWDOIN ME 04287 |
| Manufacturer Country | US |
| Manufacturer Postal | 04287 |
| Manufacturer Phone | 2076665651 |
| Manufacturer G1 | FHC, INC. |
| Manufacturer Street | 1201 MAIN ST |
| 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 | 0 |
| Brand Name | MICRO TARGETNING ELECTRODE - DZAP |
| Product Code | GZL |
| Date Received | 2015-10-16 |
| Model Number | 34685Z |
| Catalog Number | 34685Z |
| 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 ST BOWDOIN ME 04287 US 04287 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-10-16 |