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

Model Number	CT-01-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
During an initial implant of the rns system (rns neurostimulator and two leads), two burr holes were drilled and two depth electrodes were implanted (bilateral mtl leads).During the craniectomy portion of the surgery for the neurostimulator, the patient experienced excessive blood loss and concomitant hypotension.The blood loss appeared to come primarily from the site of the ferrule craniectomy.The patient's condition was severe enough that it required the neurostimulator implant to be aborted and for the patient to receive several units of blood.The patient had her craniectomy site packed with gel foam to stop the bleeding after which all incisions were ultimately closed, with gel foam packed in place.When the bleeding had apparently stopped and her vitals re-normalized, the patient was stabilized and transferred to the icu for ct/imaging/observation.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: 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 ; 5108822607
• MDR Report Key: 19713533
• Report Number: 3004426659-2024-00048
• Device Sequence Number: 15604534
• Product Code: PFN
• UDI-Device Identifier: 00855547005380
• UDI-Public: 010085554700538017261115
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CT-01-K
• Device Catalogue Number: 1007962
• Device Lot Number: 34241-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female