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 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The explanted lead was not returned to neuropace for analysis.However, review of the device ecog and lead impedance confirmed that the ecog data are suggestive of a potential lead break.

Event Description

On (b)(6) 2019, intermittent artifact was identified through ecog review, suggestive of a possible lead break in the left depth lead connected to port 2.Further review of the lead impedance and ecog data was performed and was consistent with a lead break.During a routine rns neurostimulator replacement procedure, the lead was explanted and a new lead was implanted and connected to port 2.

• 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: 9501373
• MDR Text Key: 196218459
• Report Number: 3004426659-2019-00062
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517210606
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• 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: 26124-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• 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
• Patient Age: 21 YR