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

Model Number DL-344-10-K

Device Problem Insufficient Information (3190)

Patient Problems Blurred Vision (2137); Loss of Vision (2139)

Event Date 07/17/2014

Event Type  Injury  

Event Description

In (b)(4) 2014 - the patient was implanted with the rns system.The neurostimulator was placed in the left temporal region with (1) depth lead (44cm, 10 mm) in l hippocampus, (1) depth lead (44cm, 3.5mm) in l amygdala.Patient first reported blurriness in his right lower visual field.The neurosurgeon noted "difficulty in right field of vision." patient continued to report persistent blurriness in right inferior quatrad and some troubles reading.The neurologist noted in clinic note that "he does not have a frank field cut." in (b)(6) 2014 - he was seen formally by the ophthalmologist.Ophthalmologist clinic note that there is an "area of vision loss and positive visual phenomenon.Area is close to natural blind spot but larger." in (b)(6) 2015 - the patient mentioned he was seeing an eye doctor about experiencing a visual field reduction after his implant.His condition has stayed the same.Physician adjusted the neurostimulator stimulation parameters to improve his efficacy as he is responding but not with the intent to effect his vision.Medications have remained stable and not changed during this time period.Of note is that the hippocampal depth lead used an occipital approach for placement.It is a possibility that this may have contributed to the event, but we have no information on certainty.

Manufacturer Narrative

(b)(4).The rns neurostimulator and leads remain implanted for detection and treatment of patients intractable partial onset epilepsy.Patient appears to be responding to treatment.Device remains implanted.

• 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: 4840740
• MDR Text Key: 5911357
• Report Number: 3004426659-2015-00001
• Device Sequence Number: 1
• Product Code: PFN
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: DL-344-10-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2015
• 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: 37 YR