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 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Review of the rns neurostimulator ecog data indicated a lead artifact on the right depth lead.Therapy and detection were disabled on the affected lead.No information regarding seizure-related trauma or other potential causal factors resulting in the lead break were provided by the treating center.On (b)(6) 2018 the affected lead was explanted and a new lead was implanted.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: 8853541
• MDR Text Key: 211498049
• Report Number: 3004426659-2019-00040
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417190620
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• 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: 22331-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2018
• 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: 44 YR