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); Inflammation (1932)

Event Date 09/05/2014

Event Type  Injury  

Event Description

On (b)(6) 2014: initial implant of rns neurostimulator (rns-300m-k) and (3) neuropace cortical strip leads (cl-325-10-k) placed over left occipital region, left supra-sylvian and left posterior superior.Along with (1) neuropace depth lead (dl-330-10-k) placed in the left insula.The rns system implant followed a phase ii invasive monitoring that was 7 days in duration.Intracranial electrodes (non neuropace electrodes) were removed and the rns system was implanted.On (b)(6) 2014: neurosurgeon brought patient to or to remove rns-300m-k, ferrule, (3) x cl-325-10-k and (1) dl-330-10-k for suspected wound infection.On (b)(6) 2014: communication with the neurosurgeon, werner doyle, md indicated that the patient has a wound infection that he described as a "subdural infection (empyema) and cerebritis." neurosurgeon stated that the "infection appears under control and his symptoms are resolving." on (b)(6) 2014, per the field clinical engineer, the culture was identified as an enterobacter.

Manufacturer Narrative

(b)(4).Pending 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: 4133585
• MDR Text Key: 4945223
• Report Number: 3004426659-2014-00006
• 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: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• 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: 38 YR