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

Model Number DL-330-10-K

Device Problems High impedance (1291); Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Review of the lead impedance and ecog data was performed and the data is consistent with a lead break.Neuropace received only the proximal end of the explanted lead for investigation.The portion of the lead received was received damaged and the coil was stretched.No wire breaks were found on the portion of the lead that was received, all 4 wires passed continuity test.Unable to determine root cause of the lead break.

Event Description

A review of the recorded ecog data and impedance measurements on pdms confirmed high impedances and signal artifact on the left depth lead, suggestive of a lead break.It was unclear exactly when the changes occurred between february and june as the patient was not regularly using his remote monitor.The patient did not recall falling in between the time that the signal changes were noted on the depth lead.A lead replacement was performed and a portion of the explanted lead was discarded by the hospital.A new lead was implanted and connected to the rns neurostimulator without complications and is functioning as intended.

• 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: 10782188
• MDR Text Key: 220531924
• Report Number: 3004426659-2020-00052
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517210327
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• 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: 25686-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• 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): Hospitalization; Other
• Patient Age: 22 YR