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 Problem Bacterial Infection (1735)

Event Date 10/21/2021

Event Type  Injury  

Event Description

A patient who was implanted with the rns neurostimulator and two depth leads on (b)(6)2021.On (b)(6) 2021, 80 days after the most recent procedure, the patient presented to an emergency department and scalp wound cultures were taken of the scalp wound site.Cultures confirmed mrsa, klebsiella oxytoca, raoutella ornithinolytica.On (b)(6) 2021 the patient underwent exploration of the incisions, wound wash out, incision closure and had additional cultures taken.The neurostimulator and leads were left in situ.The final culture results indicated corynebacterium and mrsa.Treatment included daptomycin once daily for 3 weeks and levaquin po for 2 weeks.

Manufacturer Narrative

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

• 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: 12910115
• MDR Text Key: 281526449
• Report Number: 3004426659-2021-00056
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617211008
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007927
• Device Lot Number: 30682-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• 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; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male