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

Model Number RNS-320-K

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

Patient Problems Pain (1994); Tingling (2171); Discomfort (2330)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The rns system remains implanted and programmed for detection.The treating center forwarded a cd containing a ct of the patient's implant to neuropace for analysis.Review of ct scan by the cmo of neuropace did not disclose anything unusual regarding rns system placement.

Event Description

At a follow-up appointment on (b)(6) 2019, the patient reported experiencing a tingling sensation in her face which started after implant, however the patient had not previously reported the issue.The patient reported feeling the face sensation (tingling) even while stimulation was disabled.The patient returned to the treating center on (b)(6) 2020 where additional testing was performed and it was determined the patient also felt the sensation when she interrogated with her remote monitor or when interrogation was performed in the clinic with the tablet programmer.Stimulation remained disabled.Potential root cause may be related to lead placement near the dura.The patient was recently seen on (b)(6) 2020 where stimulation remains disabled but the treating center has identified a plan of action including an adjustment of her aeds and a slow reintroduction of stimulation.

Manufacturer Narrative

(b)(4).On 14 aug the patient's rns neurostimulator was explanted per patient preference.There are no plans to pursue re-implantation.

Event Description

The treating center provided additional information regarding the patient's status to neuropace.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 9868147
• MDR Text Key: 187170416
• Report Number: 3004426659-2020-00009
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200304
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 27670-1-1-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR