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

Model Number RNS-320-K

Device Problems Failure to Transmit Record (1521); Communication or Transmission Problem (2896)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The explanted rns neurostimulator has not been returned to neuropace for analysis.Use of electrocautery is not recommended per manufacturer instructions as indicated in the approved rns system 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.

Event Description

The treating clinician reported that the patient's rns neurostimulator was unresponsive on (b)(6) 2020.At the same time that the device was reported as being unresponsive, the treating clinician also indicated that on (b)(6) 2020 the patient had undergone a revision of the incision at the site of the rns system placement on (b)(6) 2020 due to the development of an infection.Various troubleshooting steps were performed, including attempting to interrogate with multiple rns system tablets, which were unsuccessful at establishing communication with the device.A review of the available device data was performed and the last available device data was from an interrogation prior to the revision surgery performed on (b)(6) 2020.The clinician indicated that no plasma blade or monopolar electro-surgery was used during the revision surgery, and only minimal use of bipolar electro-surgery.The unresponsive neurostimulator was replaced on (b)(6) 2020 without complication.

Manufacturer Narrative

(b)(4) the explanted device was returned to neuropace and investigated.The returned device was investigated and testing confirmed the device had reset, consistent with 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." 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

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
• MDR Report Key: 10167824
• MDR Text Key: 195764558
• Report Number: 3004426659-2020-00019
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717201106
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: 1007694
• Device Lot Number: 29548-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 19 YR