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

Model Number 1007603

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

Patient Problem Skin Erosion (2075)

Event Date 11/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device remains implanted.

Event Description

Sn (b)(4) implanted on (b)(6) 2015.This is the patient's 4th neurostimulator.The patient is currently implanted with the rns neurostimulator and two depth leads.On 12/01/2015 neuropace was notified that the patient had dehiscence at the site of the responsive neurostimulator.Patient noticed an open area on her scalp where responsive neurostimulator is on (b)(6) 2015.Contacted neurosurgeon and was seen on (b)(6) 2015.Patient was referred to infectious disease.Clinician noted no pain and no inflammation at site.Patient did hit head on refrigerator at neurostimulator site 3 weeks prior.Unclear if this trauma opened up an already delicate area.On (b)(6) 2015 patient had an incisional erosion and was taken to surgery for a debridement procedure.Due to the erosion, the ferrule was explanted and a new ferrule was re-seated deeper into the cranial defect.A plastic surgeon closed the incision using 2 layers of interrupted sutures.No vancomycin powder was used.The new rns neurostimulator reset secondary to electrocautery the explanted neurostimulator sn(b)(4) was sent to pathology.The procedure started at 17:24 and was completed at 19:30.Impedances/signals were appropriate.No other product was opened/used.The rns system is currently programmed with detection and responsive therapy enabled.

• 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: 5323918
• MDR Text Key: 34260979
• Report Number: 3004426659-2015-00034
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017151103
• 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 Assistant
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007603
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• 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: 65 YR