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

Model Number RNS-320-K

Device Problems Failure to Interrogate (1332); Failure to Transmit Record (1521); Communication or Transmission Problem (2896)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The explanted device has not been returned to neuropace.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

Bipolar electrocautery was used during a surgical procedure to treat a hemorrhage (mfr 3004426659-2020-00038).The day after the surgical procedure (08/05/2020), attempts were made to establish communication with (e.G.Interrogate) the rns neurostimulator (both with a remote monitor and an rns system tablet), however the device was unresponsive.Therefore, the decision was made to replace the device.The rns neurostimulator was replaced without complication on (b)(6) 2020.

Manufacturer Narrative

(b)(4).The returned device was investigated and testing confirmed the reset is 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 rns neurostimulator was returned 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: 10474329
• MDR Text Key: 206113295
• Report Number: 3004426659-2020-00039
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617210212
• 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
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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: 1007927
• Device Lot Number: 29903-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR