MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for NEUROPACE RNS SYSTEM DL-330-10-K 1007605 manufactured by Neuropace, Inc..
[187170113]
(b)(4). The rns system remains implanted and programmed for use.
Patient Sequence No: 1, Text Type: N, H10
[187170114]
The patient reported starting (b)(6) 2020 their post-surgical headaches worsened, and no relief was being obtained after having tried over-the-counter medications. A ct scan was performed on (b)(6) 2020 and showed a 1. 5 x 2. 5 cm hemorrhage surrounding the electrode in the right posterior temporal lobe. The patient was subsequently admitted for further monitoring. No additional information has been provided by the treating center. The event was reported as resolved on (b)(6) 2020. No additional complications have been reported the patient is programmed for detection and stimulation and is uploading data as expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004426659-2020-00008 |
| MDR Report Key | 9844995 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2382788 |
| Manufacturer G1 | NEUROPACE, INC. |
| Manufacturer Street | 455 N. BERNARDO AVE. |
| Manufacturer City | MOUNTAIN VIEW, CA |
| Manufacturer Country | US |
| 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 | 2020-03-17 |
| Model Number | DL-330-10-K |
| Catalog Number | 1007605 |
| Lot Number | 28515-1-1-1 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-17 |