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

Model Number DL-330-10-K

Device Problems Signal Artifact/Noise (1036); Break (1069)

Patient Problems Head Injury (1879); Unspecified Infection (1930); Tissue Damage (2104)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient was implanted with the rns device sn (b)(4), 2 depth leads.Dl-330, sn (b)(4), port 1, left mesial temporal.Dl-330, sn (b)(4), port 2, right mesial temporal.Lead break was confirmed during patient evaluation.The returned lead was investigated.Lead was received damaged and in multiple pieces, unable to effectively evaluate the lead break.

Event Description

The fce reported a lead break and possible infection (due to patient fall during a seizure) at (b)(6).The patient reported the fall, which occurred on (b)(6), 5 weeks after it occurred.The patient fell backwards onto a sprinkler during a seizure.When reviewing the ecog dated (b)(6) 2017, the fall artifact is apparent and the absence of ecog signal afterwards on the right lead.The break was diagnosed via x-ray last week.The patient came in on (b)(6) 2017 with a small wound opening along her incision.There was no puss or swelling however it was red.The break was verified by creating noise on real-time ecogs and then once the incision was open, the break was very visible.The lead was removed and the site did a culture swab of the open portion of the wound.Wound debridement was performed.The patient will go home on antibiotics.No new product was implanted due to the probable infection.The rns system was programmed for detection and treatment on the date of the event.The system remains implanted and active.At this time, detection and treatment are programmed on the remaining rns system.

• 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: 6502554
• MDR Text Key: 73093190
• Report Number: 3004426659-2017-00016
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005041
• UDI-Public: 0100855547005041717101521190129
• 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
• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 47 YR