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 2020-02-13 for NEUROPACE RNS SYSTEM RNS-320-K 1007694 manufactured by Neuropace, Inc..
[187169987]
(b)(4). The explanted product was not returned to neuropace for analysis.
Patient Sequence No: 1, Text Type: N, H10
[187169988]
On (b)(6) 2020, the patient presented with wound drainage secondary to infection. On (b)(6) 2020, the rns system (neurostimulator and all leads) was explanted and the patient was treated with antibiotics. The infection was described as deep incisional by the treating center.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3004426659-2020-00004 |
MDR Report Key | 9708501 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-02-13 |
Date of Report | 2020-02-13 |
Date of Event | 2020-01-17 |
Date Mfgr Received | 2020-01-17 |
Date Added to Maude | 2020-02-13 |
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 |
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 | 2020-02-13 |
Model Number | RNS-320-K |
Catalog Number | 1007694 |
Lot Number | 28416-1-1-1 |
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. Hospitalization | 2020-02-13 |