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 2019-06-13 for NEUROPACE RNS SYSTEM RNS-300-K 1007694 manufactured by Neuropace, Inc..
[147898025]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[147898026]
The patient underwent rns system placement on (b)(6) 2019. On (b)(6) 2019, the treating center performed a debridement and irrigation of the infected incision site. On (b)(6) 2019, the rns neurostimulator and leads were explanted. Additional details were not provided by the treating center.
Patient Sequence No: 1, Text Type: D, B5
[161288682]
(b)(4). The originally submitted 3004426659-2019-00026 should have been 3004426659-2019-00023.
Patient Sequence No: 1, Text Type: N, H10
[161288683]
On (b)(6) 2019 the patient underwent a routine rns neurostimulator replacement due to expected low battery. On (b)(6) 2019, the patient underwent surgical debridement of the incision site to treat an infection. Following the debridement, the patient was noted to have developed wound erosion which was subsequently sutured closed on (b)(6) 2019. On (b)(6) 2019 the patient presented with continued erosion, and it was noted that the ferrule screw was observed through the skin erosion. The treating center scheduled the patient for surgical intervention on (b)(6) 2019. This patient has a history of scalp infections prior to implantation of the rns system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004426659-2019-00026 |
| MDR Report Key | 8695923 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-06-13 |
| Date of Report | 2019-05-29 |
| Date of Event | 2019-05-22 |
| Date Mfgr Received | 2019-05-22 |
| Date Added to Maude | 2019-06-13 |
| 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 | 2019-06-13 |
| Model Number | RNS-300-K |
| Catalog Number | 1007694 |
| Lot Number | 27147-1-1-1 |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2019-06-13 |