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

Model Number RNS-300M - KIT,

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

Patient Problem Erosion (1750)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) neurostimulator was repositioned by the neurosurgeon and scalp revised.Neurostimulator was interrogated and reprogrammed to clear dc_leak reset caused by surgery.The programmer was synchronized on (b)(6) after the programming.There was no change in lead or device placements/locations.Additional details regarding the patient - dr.(b)(6) documented the pre-surgical condition as: "breakdown of skin tissue.Left barn-door style scalp incision with thinning of the skin and exposed intracranial mesh.No associated pain or fever." on (b)(6) 2016, the patient was admitted to the hospital and had "removal of left cranioplasty material and debridement of wound.Plastic surgery performed scalp advancement flap." on (b)(6) 2016, the patient was discharged.Product remains implanted.

Event Description

Patient was implanted with the rns system on (b)(6) 2013.On 12/12/2016 the coordinator reported that the patient's "device has become visible and is exposed" per the coordinator, this was discovered by the patient's hairdresser.The patient has been doing well in regard to management of her seizures and there was no related trauma to the head.

• 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: 6238189
• MDR Text Key: 64386053
• Report Number: 3004426659-2016-00034
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2017

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: Physician
• Device Model Number: RNS-300M - KIT,
• Device Catalogue Number: 1007283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 01/10/2017
• 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: 58 YR