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

Model Number RNS-300M-K - FGI

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

Patient Problems Seizures (2063); Concussion (2192)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The patient was implanted on (b)(6) 2017, with a 44 cm/10 mm depth lead placed in the left hippocampus and a 44 cm/10 mm depth lead placed in the right hippocampus.The patient's neurostimulator was programmed in the operating room (or) with detection and ecog storage enabled.On (b)(6) 2017, the patient was confirmed to have an implant site infection at which time antibiotic treatment was initiated (refer to mdr 304426659-2017-00014).On (b)(6) 2017, the neurostimulator was programmed to deliver stimulation (82 days after initial implant and 49 days after presentation with an infection).The neurostimulator and leads were subsequently explanted as a result of the infection on (b)(6) 2017, just 28 days after stimulation was enabled.The patient data management system (pdms) is a repository of patient device data and provides clinicians with diagnostic data to assist in programming and managing a patient's neurostimulator.The rns system detects abnormal epileptiform activity as defined by the clinician, but does not function as a seizure detection device.Clinicians typically access the pdms prior to a patient's appointment to review the diagnostic data, then, with input from the patient, make clinical judgements relative to any programming changes to the patient's neurostimulator.However, in no scenario is pdms necessary for treatment changes.The patient must be seen by the physician who then uses a programmer.A review of stored ecogs and programming epoch summary data (including various device diagnostics which can provide insight into patient status) was performed by a neuropace employee with expertise in assessing device data.Remote monitor compliance for this patient (daily device interrogations with the neurostimulator) remained consistent.As such, ecog and other device diagnostic data were available for review and were consistent with the daily quantity of data uploaded since implant.However, even though some device diagnostic data was subjectively suggestive of patient improvements provided the limited amount of time when therapy was enabled, a review of these data relative to seizure frequency was not possible.More specifically, it could not be determined if stimulation had an effect on the patient's overall clinically reported seizures.In sum, there is not enough data from the neurostimulator to determine possible correlating trends between a reported increase in seizure counts due to stimulation.

Event Description

An anonymous/unidentified person ((b)(6) name (b)(6)), claiming to be the husband of an individual implanted with the rns system, posted on the neuropace (b)(6) page that his wife's neurologist "programmed my wife's rns to stimulate her brain, but it is causing seizures." he further noted that she had "already suffered a concussion from one of these falls." the implanted patient initials, physician name, and implanting/treating medical institution were not communicated.Neuropace requested contact information for the patient and her treating physician in order to connect with the patient's health care team on her behalf, however this information was not provided.

• 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: 6646362
• MDR Text Key: 77723376
• Report Number: 3004426659-2017-00027
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170703
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS-300M-K - FGI
• Device Catalogue Number: 1007603
• Device Lot Number: 22950-1-1-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 49 YR