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 Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace.

Event Description

The patient's rns neurostimulator was explanted as a result of an infection.No additional information was provided by the treating center.

Manufacturer Narrative

(b)(4).During the rns system placement procedure, the surgeon noted that the patient had adhesions due to the multiple surgeries completed in the past.On (b)(6) 2018, the patient underwent resection of the left posterior temporal region and rns neurostimulator and leads placement.On (b)(6) 2018, the patient started to complain of mild left jaw pain and woke up on (b)(6) 2018 with severe pain.At this time mother noticed that the skin overlying her neurostimulator was red and swollen.No drainage was noted from the incision site.The patient was seen in the er with subgaleal fluid collection as well as fevers.A ct scan demonstrated a large fluid collection overlying the neurostimulator incision site.The treating center aspirated the fluid which demonstrated gram-negative rods.The patient was found to have + enterobacter cloacae cns infection and was started on iv vancomycin and iv unasyn while in er.Upon confirming cns infection, the patient underwent a left craniotomy, washout, cranioplasty and explant of the rns neurostimulator and all leads on (b)(6) 2018.

Event Description

Treating center provided additional details regarding the event.

• 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: 8065910
• MDR Text Key: 126992910
• Report Number: 3004426659-2018-00043
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190813
• 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,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• 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: 26480-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• 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; Required Intervention
• Patient Age: 22 YR