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

Model Number RNS-300M

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is the patient's 4th rns neurostimulator.The device had reached end of service (was not detecting or delivering stimulation) due to routine battery depletion at the time of the event.The explanted product was not returned for investigation.

Event Description

Neuropace was informed that a patient had been explanted due to an infection when the treating site contacted neuropace to obtain information on returning the patient's remote monitor.Further information obtained from the treating center revealed that the event onset occurred on (b)(6) 2018 when the patient reported pus drainage over the incision site.However no fever or other symptoms were reported.The patient was prescribed unspecified oral antibiotics, however drainage persisted.On (b)(6) 2018 the patient presented at the emergency department with drainage and swelling, but no other symptoms.The rns neurostimulator and two depth leads were explanted.The patient had a cranioplasty with titanium mesh implanted and was prescribed vancomycin and rifampin for six weeks post-explant.

• 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: 7698798
• MDR Text Key: 114330206
• Report Number: 3004426659-2018-00022
• Device Sequence Number: 1
• Product Code: PFN
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/18/2018

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-300M
• Device Catalogue Number: 1007178
• Device Lot Number: 17401-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/18/2018
• 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: 39 YR