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

Model Number RNS-320-K

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

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

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Initial placement of the rns system occurred on (b)(6) 2020, with no issues or bleeding noted at the close of the procedure.Post-op imaging confirmed well-placed leads.However, early the next morning, the patient complained of headache and imagining confirmed a 4 cm bleed near the rns system ferrule.The patient was returned to the or to relieve the epidural hemorrhage.

• 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: 10468662
• MDR Text Key: 204871095
• Report Number: 3004426659-2020-00038
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617210212
• 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
• 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-320-K
• Device Catalogue Number: 1007927
• Device Lot Number: 29903-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• 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: 38 YR