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 2020-01-06 for NEUROPACE RNS SYSTEM RNS-300-K 1007603 manufactured by Neuropace, Inc..
[175013689]
(b)(4). The rns system remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[175013690]
On (b)(6) 2019 the patient was diagnosed by infectious disease as having a mild bacterial infection at the incision site. The patient was administered antibiotics. Per report, the patient has had an infection since the initial rns system implant, with antibiotics administered since that time and the infection resolving for periods of time but continuing to re-occur. In (b)(6) 2019 the treating center indicated an explant procedure would be scheduled to treat the infection. Additional details were not provided by the treating center.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004426659-2020-00001 |
| MDR Report Key | 9554751 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-09-11 |
| Date Added to Maude | 2020-01-06 |
| 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 | 2020-01-06 |
| Model Number | RNS-300-K |
| Catalog Number | 1007603 |
| Lot Number | 23771-1-1-1 |
| 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; 2. Required No Informationntervention | 2020-01-06 |