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 2019-05-17 for NEUROPACE RNS SYSTEM DL-344-3.5-K 1007606 manufactured by Neuropace, Inc..
[145481934]
(b)(4). No indication of product failure.
Patient Sequence No: 1, Text Type: N, H10
[145481935]
The patient underwent a planned staged rns system implant procedure, with the rns system leads placed during the initial procedure on (b)(6) 2019. The rns neurostimulator was not implanted at that time, with placement planned for a future procedure. No complications were reported during the lead placement. On (b)(6) 2019 the treating center reported that the patient had decreased coordination of the left hand. The patient was diagnosed with cerebral edema attributed to the surgical procedure associated with the implant of the two leads. The treating center noted that this was an anticipated event. Treatment included dexamethasone and one night of hospitalization for observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004426659-2019-00018 |
| MDR Report Key | 8621999 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-04-19 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-05-17 |
| 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 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 | 2019-05-17 |
| Model Number | DL-344-3.5-K |
| Catalog Number | 1007606 |
| Lot Number | 22640-1-1-1 |
| 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. Hospitalization | 2019-05-17 |