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

Model Number CL-335-10-K

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

Patient Problems Intracranial Hemorrhage (1891); Cerebral Edema (4403)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The rns system remains implanted and programmed for use.

Event Description

Per report number mfr #(b)(4), the event is described as follows: "patient admitted to hospital with stroke symptoms.Subsequent, imaging revealed brain hemorrhage at the site of one of the electrodes originally placed in [date redacted] at another facility." despite multiple attempts by neuropace to obtain additional information regarding evaluation of or relation/causality of the rns system to the event described in the medical device report, no additional information has been provided by the treating clinician or reporting center to-date.The only information provided has been that the patient is currently stable and has been placed in a rehabilitation facility.

Event Description

Additional details were provided by the treating physician.

Manufacturer Narrative

(b)(4).Additional details were provided by the treating physician.The patient experienced a brainstem hemorrhage (intraparenchymal and subarachnoid) with edema extending to left mid brain, cerebral peduncle and thalamus.No neuropace product was located near the origin of the bleed.Supportive care was provided initially with patient subsequently discharged to an acute rehabilitation facility.The patient was re-admitted to the icu with hydrocephalus and underwent evd and eventually lp shunt placement.Patient underwent additional acute rehabilitation treatment.Onset date was clarified as (b)(6) 2020.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 10840481
• MDR Text Key: 216417156
• Report Number: 3004426659-2020-00062
• Device Sequence Number: 1
• Product Code: PFN
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CL-335-10-K
• Device Catalogue Number: 1006035
• Device Lot Number: 14435-1-1-4
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR