MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number RNS-300-K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Hemorrhage, Subdural (1894)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The rns system remains implanted and programmed for use.

Event Description

During review of adverse event data for an investigator initiated retrospective data collection study, a serious adverse event was identified that had not previously been reported to neuropace.The event, reported as related to the rns system implant, involved the patient developing a subdural hemorrhage causing headache and photophobia.The event self-resolved without surgery but required a longer hospitalization.No other details were provided.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, ca ; 2382788
• MDR Report Key: 10466617
• MDR Text Key: 204871571
• Report Number: 3004426659-2020-00034
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170615
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-300-K
• Device Catalogue Number: 1007603
• Device Lot Number: 22888-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR