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 2020-01-21 for NEUROPACE RNS SYSTEM RNS-320-K 1007694 manufactured by Neuropace, Inc..
[176209367]
(b)(4). The explanted product was not returned to neuropace for analysis.
Patient Sequence No: 1, Text Type: N, H10
[176209368]
Neuropace was notified that the treating clinician was reporting unspecified difficulties interrogating the patient's rns neurostimulator using the rns? Tablet during a clinic appointment. Further troubleshooting was performed, including the use of different rns? Tablet and wands to interrogate, however the rns neurostimulator was still unable to be interrogated. The treating clinician and patient stated that the device had not been exposed to mri or any surgical procedures involving the use of electrocautery. Review of device data indicated that the device was functioning normally as of (b)(6) 2019. However, no further data or communication with the device was present after that date. The patient was subsequently scheduled for a neurostimulator replacement procedure on (b)(6) 2020 which occurred without complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004426659-2019-00060 |
| MDR Report Key | 9612597 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-03 |
| Date Mfgr Received | 2020-01-03 |
| Date Added to Maude | 2020-01-21 |
| 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 | 2020-01-21 |
| Model Number | RNS-320-K |
| Catalog Number | 1007694 |
| Lot Number | 25944-1-1-1 |
| 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. Other | 2020-01-21 |