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

Model Number DL-330-10

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

Patient Problems Impaired Healing (2378); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

In (b)(6) 2019, the patient noted a protrusion and some fluid leaking around a portion of the rns system incision site.The patient was scheduled for a revision procedure on (b)(6) 2020.During the procedure, it was determined that one of the unconnected, capped leads was applying outward pressure near the incision line, preventing proper healing.The neurosurgeon re-positioned the lead, securing it away from the incision site.No further information was provided by the treating center.

• 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: 9614122
• MDR Text Key: 187169924
• Report Number: 3004426659-2020-00002
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517220411
• 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: Physician
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DL-330-10
• Device Catalogue Number: 1007605
• Device Lot Number: 27875-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2020
• 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): Required Intervention
• Patient Age: 31 YR