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

Model Number 1007607

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

Patient Problem Swelling (2091)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device not returned.

Event Description

Patient had initial implant of the rns system on (b)(6) 2016.Patient was implanted with rns neurostimulator and two depth leads both implanted within the right frontal cortex.Approximately 2 weeks post op, patient developed a new seizure type and left side weakness.Patient was admitted to the hospital and received a ct scan and results revealed intra-cranial swelling at the site of superior depth lead located in the right frontal cortex.Infection, stroke and meningitis were ruled out by lab work-up and imaging.Patient was started on a course of iv steroids in an effort to reduce swelling at the superior depth lead site.On (b)(6) 2016 patient was taken to the or for removal of superior right frontal depth lead as swelling did not decrease significantly.Patient's neurostimulator and inferior right frontal depth lead remain implanted.Patient was discharged from the hospital on (b)(6) 2016 and was transferred to an acute rehab facility due to lack of patient support at home.

• 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: 5884202
• MDR Text Key: 52380444
• Report Number: 3004426659-2016-00021
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417180120
• 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: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2016
• 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