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

Model Number	RNS-320-K
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported she was unable to interrogate her device on (b)(6) 2021.The last successful interrogation was observed on (b)(6) 2021.During her clinic visit on (b)(6) 2021, the neuropace fce was unable to interrogate the device.Attempts were made using two different tablets and wands.There is no report of procedures or falls that may have contributed to an unresponsive device.Neurostimulator replacement occurred on (b)(6) 2021.Neuropace received the explanted product on (b)(6) 2021.The returned neurostimulator was successfully interrogated when it was received and is currently undergoing additional investigation.
Additional Manufacturer Narrative
(b)(4) explant of the neurostimulator occurred on (b)(6) 2021.Neuropace received the device on 03 nov 2021.The returned neurostimulator was successfully interrogated when it was received and is currently undergoing additional investigation.
Event or Problem Description
Investigation results are now available.The initial report indicated the neurostimulator was unresponsive and required explant.Neuropace received the explanted product on (b)(6) 2021.
Additional Manufacturer Narrative
(b)(4).This device stopped supporting successful interrogations by the patient remote monitor and the physician's programmer sometime between the dates of (b)(6) 2021 and (b)(6) 2021.While in this state, the device recorded evidence of receiving telemetry but failed to acknowledge or respond.During the time telemetry was unsupported the device continued to function normally, providing responsive therapy and storing ecog's and diagnostics.The cause of the device state during this time is unknown.Explant of the neurostimulator occurred on (b)(6) 2021.The device returned to fully normal operation including full telemetry support upon device explant.The explant procedure exposed the device to an electrosurgical unit (esu) which apparently caused a dc_leak reset, returning the device to fully normal operation.It is common for a device to experience a dc_leak reset in response to esu exposure.Neuropace received the device on (b)(6) 2021.Upon receipt, the neurostimulator appeared to be functioning properly.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: 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: 12856013
• Report Number: 3004426659-2021-00049
• Device Sequence Number: 4005861
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200809
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 29126-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Age: 40 YR
• Patient Sex: Female