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

Model Number	DL-330-10-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).At the time of the event, review of the device ecog and lead impedances confirmed that the ecog data were suggestive of a potential lead break.Investigation of the returned lead confirmed lead damage.The lead coil has a kink about 12 cm from the distal end.Root cause was not identifiable.
Event or Problem Description
During a routine review of the patient's neurostimulator ecog data on (b)(6) 2016, it was noticed that there was a signal loss on the left depth lead.The treating clinician stated that the patient's mother indicated that the patient fell from bed in (b)(6).The patient was seen by the treating center on (b)(6) 2016 at which time stimulation was disabled on that lead; however stimulation remained enabled on the other lead and the patient continued to be treated with responsive stimulation.The depth lead was replaced on (b)(6) 2019 during a routine battery replacement.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 8701930
• Report Number: 3004426659-2019-00024
• Device Sequence Number: 13866892
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517180110
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 20016-1-1-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR