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

Model Number DL-344-10-K

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the explanted lead was not returned to neuropace for analysis.Review of the patient device data confirmed that the ecog data were suggestive of a potential lead break.

Event Description

Review of the rns neurostimulator ecogs indicated an artifact on the left depth lead connected to port 1.On (b)(6) 2017 during clinic, the treating clinicians palpated around the generator and the lead entry site, but were not able to clearly induce similar artifact noted previously.The patient does not recall falling around the time that the artifact signal was noted but does experience seizures where he loses awareness and falls.On (b)(6) 2018 the affected lead was explanted and a new depth lead implanted and connected to port 1.No complications were reported during the procedure.

• 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: 8852641
• MDR Text Key: 211498525
• Report Number: 3004426659-2019-00041
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417190629
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL-344-10-K
• Device Catalogue Number: 1007607
• Device Lot Number: 22346-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/01/2019
• 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: 23 YR