MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-10 for NEUROPACE RNS SYSTEM DL-330-10-K 1007605 manufactured by Neuropace, Inc..
[144707896]
(b)(4). No indication of product failure.
Patient Sequence No: 1, Text Type: N, H10
[144707937]
The patient presented with a headache on (b)(6) 2019, the day after implant with the rns system neurostimulator and leads. Fluid leakage was observed from the left burr hole cover incision site and was repaired by the center. The patient was brought back to the operating room on (b)(6) 2019 for removal of the lead and additional repair of the csf leak. Patient was discharged on (b)(6) 2019. No further details were provided by the treating center.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004426659-2019-00016 |
| MDR Report Key | 8599731 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-04-13 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-05-10 |
| 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 | MRS. RAMONA GONIS |
| Manufacturer Street | 455 N. BERNARDO AVE. |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal | 94043 |
| Manufacturer Phone | 6502382788 |
| Manufacturer G1 | NEUROPACE, INC. |
| Manufacturer Street | 455 N. BERNARDO AVE. |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94043 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROPACE RNS SYSTEM |
| Generic Name | NEUROPACE RNS SYSTEM |
| Product Code | PFN |
| Date Received | 2019-05-10 |
| Model Number | DL-330-10-K |
| Catalog Number | 1007605 |
| Lot Number | 27392-1-1-1 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROPACE, INC. |
| Manufacturer Address | 455 N. BERNARDO AVE. MOUNTAIN VIEW CA 94043 US 94043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-10 |