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

Model Number RNS-300M-K

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 10/14/2014

Event Type  Injury  

Event Description

On (b)(6) 2012 - patient had neurostimulator replacement surgery.The patient was implanted with a rns neurostimulator, (2) cl-325-10 cortical strip leads , and (1) dl-344-3.5 depth lead.On (b)(6) 2014 - patient returned to clinic and presented with erosion at incision line in vicinity of rns neurostimulator.Drainage was occuring.All implantable product was removed by dr.(b)(6).Infection is noted to be a soft tissue infection.Pathology reports - swab cultures were positive for some gram positive cocci and pseudonomous.Blood cultures were negative.Patient is in good condition with no neurological deficits.

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: 4244201
• MDR Text Key: 5018282
• Report Number: 3004426659-2014-00015
• 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: Physician
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• 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
• Date Manufacturer Received: 10/15/2014
• 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: 35 YR