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

Model Number RNS-320-K

Device Problem Failure to Interrogate (1332)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The explanted rns neurostimulator was returned to neuropace.The investigation is in process.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 i permanent damage to device operation.".

Event Description

During the surgical procedure, it was noted that the bovie electrosurgery cautery cord was unplugged but the bipolar forceps remained plugged in.The rns neurostimulator was handed across the sterile field for implant, and was connected to the leads.Testing of the neurostimulator confirmed the device was functional at that time.The neurosurgeon then closed the incision using bipolar cautery.Once the incision was closed and while still in the sterile environment, the neurostimulator was again interrogated.The device failed to communicate with the programmer at that time.Troubleshooting was performed with multiple programmer wands and programmers.The incision was reopened and a new rns neurostimulator implanted.

Manufacturer Narrative

(b)(4) - analysis of the returned rns neurostimulator confirmed that the device was non-responsive to telemetry consistent with a device state resulting from esu exposure.

Event Description

The returned product was 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: 8869433
• MDR Text Key: 153540595
• Report Number: 3004426659-2019-00031
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200325
• 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: 08/20/2019

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 Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 27925-1-1-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR