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

Model Number RNS-320-K - FGI

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

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Impaired Healing (2378)

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2023, the patient reported incisional tenderness and the sensation of "pressure" along with slight redness.The patient was started on cephalexin orally.At the wound check visit on (b)(6) 2023, a small wound opening and moderate amount of purulent drainage was observed.The patient was admitted to the hospital for debridement and washout of the incision site.Cultures were collected resulting in growth of pseudomonas, while the patient was on iv antibiotics.Iv antibiotic zosyn was prescribed and continued postoperatively.The patient developed neutropenia while on zosyn and therefore the antibiotic was changed to cefepime.On 10/20/2023, the incision site had failed to fully close, the rns neurostimulator and hardware were explanted.Treatment included continuation of antibiotics.Antibiotics treatment details were as follows: cephalexin (b)(6) 2023, cefepime (b)(6) 2023, vancomycin (b)(6) 2023, piperacillin-tazobactam (b)(6) 2023, cefepime (b)(6) 2023, piperacillin-tazobactam (b)(6) 2023, ciprofloxacin (b)(6) 2023-eot (b)(6) 2023.The patient continues to recover from the 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 ; 5108822607
• MDR Report Key: 18173629
• MDR Text Key: 328566313
• Report Number: 3004426659-2023-00054
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617240110
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/13/2023

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 Model Number: RNS-320-K - FGI
• Device Catalogue Number: 1008191
• Device Lot Number: 33183-1-1-1
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/20/2023
• 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: 48 YR
• Patient Sex: Female