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 Wound Dehiscence (1154); Bacterial Infection (1735); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) the explanted product was not returned to neuropace for analysis.

Event Description

Neuropace was informed that the patients rns system (neurostimulator and all leads) was explanted to treat an infection.Additional information was not provided by the treating center.

Event Description

Additional details were provided by the treating center.

Manufacturer Narrative

(b)(4).The treating center provided additional details regarding the event.The patient presented on (b)(6) 2020 with dehiscence and fluid build-up at the rns neurostimulator incision site.The resulting infection from the dehiscence was diagnosed as a superficial incisional infection.Treatment included antibiotics and explant of the rns neurostimulator.

• 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: 11468032
• MDR Text Key: 239389425
• Report Number: 3004426659-2021-00017
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617210303
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

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: 30015-1-1-1
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR