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 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rns neurostimulator was not returned to neuropace for analysis.Review of the rns neurostimulator data indicated that the device was performing as expected prior to incision closure.Use of electrocautery is not recommended per manufacturer instructions as indicated in the approved rns system labeling."risks regarding the use of electrocautery is addressed in the rns® system physician manual.The approved labeling states: "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

During the initial implant procedure, testing of the rns neurostimulator prior to closure of the surgical incision indicated that the device was functioning as expected.Once the incision was closed, a final test of the device was performed.The neurostimulator did not respond during testing at that time.Several attempts were made to interrogate using alternative wands and tablets but were unsuccessful.The non-responsive device was then explanted and a new rns neurostimulator implanted.It is not clear if esu (electro-surgery use) was used during the incision closing process.

Manufacturer Narrative

(b)(6).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.Risks regarding the use of electrocautery are addressed in the rns® system physician manual.The approved labeling states: "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 product was received and investigated by neuropace.

• 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: 8925816
• MDR Text Key: 207925981
• Report Number: 3004426659-2019-00036
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200418
• 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: 10/28/2019

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: 28105-1-1-1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR