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 07/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient noted an area of concern in the right occipital area, a small area of dense involuted scar without purulence in the region of the rns system incision site.The area was explored and found to have dense reactive tissue changes consistent with a chronic skin infection.The wound was washed out and the incision site revised.The patient was admitted for infectious disease consult and antibiotic treatment, and was recommended to undergo picc line placement and 4 weeks of outpatient daptomycin therapy the patient tolerated the treatment well, but in follow up with infectious disease, concern was expressed that given the patient's implanted hardware the infection would unable to be effectively cleared, and a complete hardware removal was recommended.The patient underwent complete rns system removal on (b)(6) 2020.Diagnosed as a deep incision infection.

• 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: 10505625
• MDR Text Key: 206113098
• Report Number: 3004426659-2020-00047
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200718
• 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 Assistant
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 28798-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• 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): Other
• Patient Age: 47 YR