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

Model Number RNS-300M-K

Device Problem Insufficient Information (3190)

Patient Problem Hydrocephalus (3272)

Event Date 08/22/2014

Event Type  Injury  

Event Description

On (b)(6) 2014: patient implanted with neuropace neurostimulator (rns-300-m-k) and (4) neuropace cl-325-10 cortical strip leads placed subdurally on the temporal and parietal lobes.On (b)(6) 2014: programmable shunt was placed due to hydrocephalus.Neurostimulator and cortical strip leads remain implanted.On (b)(6) 2014: physician reports that the patient is doing well post shunt replacement.Patient reports no seizures in the past 30 days.Neurostimulator is enabled for both detection and responsive stimulation.(b)(4).

Manufacturer Narrative

(b)(4).No product to be returned.No product return.

• 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: 4136884
• MDR Text Key: 4931479
• Report Number: 3004426659-2014-00009
• Device Sequence Number: 1
• Product Code: PFN
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RNS-300M-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2014
• 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: 24 YR