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

Model Number RNS-300-K

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

Patient Problem Discomfort (2330)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient reported discomfort near implant site since the initial rns system placement.The issue was assessed by the neurosurgeon and found not to be a serious issue and would be addressed when the patient was scheduled for a subsequent procedure.The patient decided to pursue surgery sooner and on (b)(6) 2019, the neurosurgeon found a small amount of bone cement near the top of the device which was causing the discomfort.Bone cement is used by this center to cover burr holes.The bone cement was removed and no further complications were reported.

• 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: 8798424
• MDR Text Key: 151303172
• Report Number: 3004426659-2019-00029
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-300-K
• Device Catalogue Number: 1007603
• Device Lot Number: 22530-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2019
• 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): Other
• Patient Age: 52 YR