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

Model Number RNS 320

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

Patient Problem Wound Dehiscence (1154)

Event Date 05/12/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 the patient was evaluated for wound dehiscence.The patient was last seen in neurosurgery clinic at the 2-week post-op visit ((b)(6) 2021).During the post-op visit ((b)(6) 2021), when the staples were removed, the incision was noted to be healing well.The patient appears to have missed the 6-week follow up appointment.The patient reported he first noticed the wound breakdown when the skin at the region felt "off" when he was taking a shower.When he reached up and felt his scalp, he could feel the hardware.The mother inspected the site and took him to the emergency room.The day prior, he had some mild itching at the site.In the weeks prior, he noted intermittent drops of what felt like fluid coming from the incision site.There was no report of any recent trauma or notable infections at the region.The patient had been swimming more than normal, but denied swimming until the wound was fully healed.No recent episodes of fevers/chills.He feels that the rns is still functioning appropriately and seizure reduction after activation has remained stable.The patient was admitted (b)(6) 2022 and hospitalized through (b)(6) 2022.Treatment included explant of the neurostimulator and two leads.Additional details were not provided.

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace for analysis.

• 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: 14961420
• MDR Text Key: 295599913
• Report Number: 3004426659-2022-00015
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617220407
• 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 Practitioner
• Type of Report: Initial
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS 320
• Device Catalogue Number: 1007927
• Device Lot Number: 31244-1-1-1
• Date Manufacturer Received: 06/29/2022
• 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): Other; Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male