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 Problem Hematoma (1884)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Following initial rns system placement on (b)(6) 2020, the patient experienced an epidural hematoma resulting in unilateral right-sided weakness.Treatment included surgical evacuation of the blood clot and suturing of the sagging dura to the skull.The rns system remains implanted.Additional details not provided by the treating center.

• 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: 9860624
• MDR Text Key: 187170011
• Report Number: 3004426659-2020-00007
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717201001
• 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: Physician
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• 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: 1007694
• Device Lot Number: 29298-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2020
• 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: 49 YR