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 Convulsion/Seizure (4406)

Event Date 10/14/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.

Event Description

Patient underwent an rns neurostimulator programming change on thursday, (b)(6) 2022.During the car ride home after the rns adjustment, the patient reportedly experienced right arm tonic posturing.On saturday (b)(6), 2022 the patient was admitted to the icu after experiencing a significant seizure lasting more than 30 minutes.Patient has returned home with no additional reports of cluster seizures.No change was made to programming.

• 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: 15801667
• MDR Text Key: 303702320
• Report Number: 3004426659-2022-00046
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617220526
• 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
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• 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: 31631-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• 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): Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female