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

Model Number RNS-320-K

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

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

Event Date 04/27/2021

Event Type  malfunction  

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 system labeling.The approved labeling states: "risks regarding the use of electrocautery is addressed in the rns® system physician manual.The use of electrocautery (electro-surgery) 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." if electrocautery is necessary, the following recommendations may be effective in minimizing potential future complications.During a surgical procedure where bipolar electrocautery is used: keep the electrocautery tip more than 2 cm (approximately one inch) from the implanted device.The selected output power of the electrocautery unit should be as low as possible for the relevant application and not used for greater than 10 seconds in any one burst.

Event Description

Telemetry with the rns neurostimulator was unable to be established following a suture removal.Troubleshooting was performed but no telemetry could be established.No information was provided as to the equipment used during the suture removal; however it is suspected that electrocautery was used, rendering the device nonfunctional.The patient underwent replacement of the device without complication on (b)(6) 2021.

Manufacturer Narrative

(b)(4).Investigation of the returned device included electrical measurements which were indicative that the device failed due to an electro-surgery use (esu) exposure use of electrocautery is not recommended per manufacturer instructions as indicated in the approved rns system labeling.The approved labeling states: "risks regarding the use of electrocautery is addressed in the rns® system physician manual.The use of electrocautery (electro-surgery) 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.".

Event Description

The explanted device was returned to neuropace and investigated.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 11887264
• MDR Text Key: 263488132
• Report Number: 3004426659-2021-00023
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617211008
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007927
• Device Lot Number: 30682-1-1-1
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR