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

Model Number RNS-300M-K

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

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 06/10/2014

Event Type  Injury  

Event Description

(b)(6) 2014 patient underwent neurostimulator replacement due to neurostimulator battery reaching elective replacement period.This is her fifth device.Patient is implanted with four cortical strip leads.The patient presented with drainage at the neurostimulator incision site.Appears to be a soft tissue infection.No fever, vomiting or nausea was reported.No indications of device malfunction at explant.(b)(6) 2014 dr.(b)(6) contacted the fce (field clinical engineer) requesting experienced recommendations regarding treatment.(b)(6) 2014 (b)(6) sent email to the fce indicating that he was in the process or removing entire rns system after discussion with patient and family.Surgeon indicated patient will not be a candidate for reimplantation of rns system as patient did not receive desired efficacy.There is no indication of product malfunction.

Manufacturer Narrative

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

• 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: 4203732
• MDR Text Key: 21967080
• Report Number: 3004426659-2014-00013
• 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: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• 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: 09/30/2014
• 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: 29 YR