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

Model Number 1007603

Device Problems Device Remains Activated (1525); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial implant, rns and two depth leads.Port 1, dl-344-10, sn (b)(4), left mesial temporal.Port 2.Dl-330-10, sn (b)(4), right mesial temporal.

Event Description

Patient was implanted with the rns system on (b)(6) 2017 with no intraoperative complications.A routine post-op scan was performed which did not demonstrate any hemorrhage or acute changes.On (b)(6) 2017, the patient noticed an acute change in vision loss.A ct scan of the head was obtained showing a new right occipital intracerebral hemorrhage along the tract of the right depth electrode.Patient was neurologically intact except for confusion and a new left-sided field cut in bilateral eyes.Patient was moved to the neurological icu and had serial ct head scans performed which did not show any evolution of the hemorrhage.Of note, the patient did not receive her dvt (deep vein thrombosis) prophylaxis before the spontaneous hemorrhage.Patient was seen by pt (physical therapy) and ot (occupational therapy) during the hospitalization; however no surgical intervention was performed for the hemorrhage.Patient was discharged on 7/10/2017, as the patient was still symptomatic (disorientation, imbalance and left eye vision loss) she was admitted to an inpatient rehab facility on the 19th.Per patent's husband, the patient is doing better.

• 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: 6803728
• MDR Text Key: 83032257
• Report Number: 3004426659-2017-00035
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017171013
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR