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

Model Number CL-325-10-K

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient has a pre-implant history of non-epileptic events with bilateral sensory phenomena with no electrographic correlate seen on recorded ecogs after implant with the rns system.The symptoms progressed post-implant from bilateral sensory symptoms to distal left hand weakness which spread to involve the entire arm.Due to the progression of the symptoms, the patient presented at the emergency department where a head ct was performed that identified an intraparenchymal hemorrhage located adjacent to the unconnected strip lead.Multiple mris were performed 11/1/2020- 11/4/2020 which indicated a change in location of the unconnected strip lead since initial implant.On 11/05/2020 the patient was taken to the or for surgical evacuation of the hemorrhage and removal of the unconnected strip lead.

• 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: 10953128
• MDR Text Key: 219900517
• Report Number: 3004426659-2020-00060
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917210109
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CL-325-10-K
• Device Catalogue Number: 1007609
• Device Lot Number: 25264-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• 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; Required Intervention
• Patient Age: 17 YR