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

Model Number RNS-300M

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

Comp-(b)(4).Implant date (b)(6) 2016.The patient was implanted with the rns and three depth leads (dl-330 port 1, left parietal posterior inferior, dl-344 port 2 left frontal anterior superior, dl-330 not connected 2 left frontal anterior inferior and dl-300 not connected left posterior superior) the rns system is currently programmed for detection and treatment.Implant details procedure 1.5 hrs, no vancomycin powder used.No invasive monitoring, no vns (b)(6) 2016: lumbar drain placement.(b)(6) 2016: lumboperitoneal shunt.Product remains implanted.

Event Description

Persistent csf leak following rns implantation, developed through incision.Lumbar drain placed for several days.Attempts to wean were followed by recurrent csf leaks.Csf shunt placed to achieve adequate wound healing and reduce risk of infection.

• 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: 6245527
• MDR Text Key: 64621480
• Report Number: 3004426659-2016-00035
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170330
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS-300M
• Device Catalogue Number: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• 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: 52 YR