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

Model Number RNS-320M-K

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

Patient Problem Edema (1820)

Event Date 07/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The patient had his first rns system explanted in (b)(6) 2016 as a result of an infection.(reference (b)(4), mfr 3004426659-2016-00004).

Event Description

On (b)(6) 2018 the patient underwent monitoring as well as re-implantation of the rns neurostimulator and leads.On approximately (b)(6) 2018 the patient developed a generalized edema around the left hemisphere which was confirmed by ct scan.A change in lead impedance was noted on (b)(6) 2018.This change in impedance was attributed to the edema.By (b)(6) 2018 the edema had reduced and impedances appeared to be returning to baseline.The development of edema was not attributed to the rns neurostimulator or leads by the treating center.The edema was felt to be a normal surgical complication to implant a cranial medical device.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 6502382788
• MDR Report Key: 7815305
• MDR Text Key: 241263593
• Report Number: 3004426659-2018-00033
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190326
• 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: Physician
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-320M-K
• Device Catalogue Number: 1007694
• Device Lot Number: 25875-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2018
• Initial Date FDA Received: 08/24/2018
• 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: 35 YR