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

Model Number RNS 320

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/10/2022

Event Type  Death  

Event Description

Patient underwent implantation of rns neurostimulator and left mesial temporal and left orbitofrontal leads on (b)(6) 2022.He had an acute decline in level of consciousness early morning on (b)(6) 2022.A ct scan of the head showed a large left frontal lobe hemorrhage at the site of the orbitofrontal lead.The patient was taken to the emergency operating room for evacuation of the hemorrhage and removal of the rns system.Diagnosed as an intraparenchymal hemorrhage.

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace for analysis.

Event Description

Patient underwent implantation of rns neurostimulator and left mesial temporal and left orbitofrontal leads on (b)(6) 2022.He had an acute decline in level of consciousness early morning on (b)(6) 2022.A ct scan of the head showed a large left frontal lobe hemorrhage at the site of the orbitofrontal lead.The patient was taken to the emergency operating room for evacuation of the hemorrhage and removal of the rns system.Diagnosed as an intraparenchymal hemorrhage.The patient passed on (b)(6) 2022 at secu unc hospice home.Per the physician on record, the family, after seeing a lack of recovery and limited prognosis, made a decision to withdraw his care.

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace for analysis.

• 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: 15383449
• MDR Text Key: 299558169
• Report Number: 3004426659-2022-00032
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617230201
• 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,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS 320
• Device Catalogue Number: 1008191
• Device Lot Number: 32392-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• 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): Life Threatening; Other; Death; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male