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

Model Number RNS-320-K

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

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Visual Impairment (2138); Hypoesthesia (2352)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient underwent initial placement of the rns system on (b)(6) 2021.Following the implant procedure the patient was observed to have: 1) reduced strength of her right arm, 2) reduced sensory perception on her right hand and 3) a visual field cut.After review, an attending stroke specialist at the treating center stated these symptoms are consistent with a stroke of the anterior choroidal artery (aca).A ct scan was performed and an area of ischemia, but not a hemorrhage, was noted in the vicinity of the aca near the left lead.The final diagnosis was aca flow restriction.Treatment includes rehab care and ongoing imaging was performed to monitor the event.The event is attributed to the implant procedure.

• 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: 11816990
• MDR Text Key: 250364532
• Report Number: 3004426659-2021-00025
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617211120
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/12/2021

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 Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007927
• Device Lot Number: 30846-1-1-1
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/13/2021
• 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): Other
• Patient Age: 45 YR