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

Model Number DL-344-3.5-K

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A review of the patient's ecog data indicated signal artifact on the left depth lead (port 1) starting on (b)(6) 2018, suggestive of a possible lead break.The patient was scheduled for a routine rns neurostimulator replacement and replacement of the lead in (b)(6) 2019.Subsequently, the patient's right depth lead connected to port 2, demonstrated similar issues starting on (b)(6) 2019.No information regarding seizure-related trauma or other potential causal factors resulting in the lead breaks were provided by the treating center.During the surgical procedure on (b)(6) 2019, both leads were removed and two new depth leads were implanted and connected to the rns neurostimulator without complication.

• 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: 8498193
• MDR Text Key: 141429865
• Report Number: 3004426659-2019-00012
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005021
• UDI-Public: 010085554700502117191214
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL-344-3.5-K
• Device Catalogue Number: 1007606
• Device Lot Number: 23112-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2019
• 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: 41 YR