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

Model Number RNS NEUROSTIMULATOR

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Fluid Discharge (2686)

Event Date 07/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) patient enrolled in clinical trial.Device remains implanted.

Event Description

(b)(6) 2015: neurostimulator replaced at elective replacement indicator.There was a change in neurostimulator location from the skull to pectoral region, neuropace leads were explanted and there was an implant/connection to non-neuropace leads.The subject was implanted with the rns neurostimulator and (2) medtronic 3987a leads and (2) medtronic lead extensions 37086.The device was placed in the left pectoral region.The rns system is approved as a cranial implant with neuropace cortical strip and depth leads.(b)(6) 2015: the subject was seen in the er for clear chest incision drainage and a rash around the incision on her chest.The surgical site was cleaned with chlorhexidine prep solution and a dry dressing placed on it.Surgical intervention was not required and no antibiotics given.The patient was in the er for less than 24 hrs.Labs were also done while in er.The patient reported no seizures in the er.(b)(6) 2015: the lab report states no fungi isolated-culture in progress, another states no acid fast bacilli isolated- culture in progress, and another states no growth aerobically or anaerobically.The neurostimulator and medtronic leads remain implanted.

Manufacturer Narrative

Correction to device serial number (b)(4).Device is labeled for single use-yes.Device remains implanted.

Event Description

(b)(4).

• 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: 5024960
• MDR Text Key: 23847458
• Report Number: 3004426659-2015-00023
• 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: Physician
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS NEUROSTIMULATOR
• Device Catalogue Number: RNS-300M-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• 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: 44 YR