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

Model Number RNS 320

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

During the implant of a new lead the surgeon used an electrosurgical device, rendering the rns neurostimulator unresponsive.

Manufacturer Narrative

(b)(4).Neuropace is pending return of the explanted product.Use of electrocautery is not recommended per manufacturer instructions as indicated in the approved rns neurostimulator and leads labeling.The use of electrocautery (electrosurgery) can affect the operation of neurostimulators.The rns® system has been designed to prevent or minimize the effects of electrocautery, however the energy levels used in electrocautery can temporarily interfere with or cause permanent damage to device operation.Electrocautery applied near the rns® neurostimulator may cause it to temporarily stop sensing, delivering therapy, or may reset the neurostimulator.Under these conditions the neurostimulator may require interrogation and possible reprogramming.Electrocautery applied directly to the neurostimulator or leads may couple enough energy into a neurostimulator system to damage brain tissue.

• 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: 14431183
• MDR Text Key: 300247389
• Report Number: 3004426659-2022-00010
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617210903
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/17/2022

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 Model Number: RNS 320
• Device Catalogue Number: 1007927
• Device Lot Number: 30531-1-1-1
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 31 YR
• Patient Sex: Male