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

Model Number DL-330-10-K

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  Injury  

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 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
• 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: 8701930
• MDR Text Key: 148139701
• Report Number: 3004426659-2019-00024
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517180110
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/14/2019
• 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): Other
• Patient Age: 25 YR