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

Model Number RNS-300M-K

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058); Fluid Discharge (2686)

Event Date 08/31/2014

Event Type  Injury  

Event Description

(b)(6) 2014: patient implanted with neuropace neurostimulator (rns-300-m-k) and (2) neuropace dl-344-10 depth leads placed in the right and left hippocampus.(b)(6) 2014: patient returned to clinic and presented with drainage from incision near rns neurostimulator.Patient taken to the or and the rns system including ferrule, leads and neurostimulator were removed.Pathology report was positive for (b)(6).The patient was discharged and in stable condition, no neural deficits were reported.

Manufacturer Narrative

(b)(4).No product to be returned.

• 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: 4116218
• MDR Text Key: 4701186
• Report Number: 3004426659-2014-00010
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/12/2014

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: Health Professional
• Device Model Number: RNS-300M-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 09/24/2014
• 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
• Patient Age: 42 YR