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 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Use of electrocautery is not recommended per manufacturer instructions."risks regarding the use of electrocautery is addressed in the rns® system physician manual.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".The explanted product was not returned to neuropace for investigation.

Event Description

On (b)(6) 2019 the patient underwent a debridement procedure to treat an ingrown hair found in the surgical scar from the rns system placement procedure.Stimulation and detection were disabled prior to the procedure.A plasma blade was used during the procedure to dissect the scar tissue near the rns neurostimulator when addressing the ingrown hair.When attempting to re-enable detection and stimulation the day after the procedure, the physician was unable to communicate with the neurostimulator.The neurostimulator was subsequently replaced on (b)(6) 2019.

Event Description

Investigation results available.

Manufacturer Narrative

(b)(4).The product was returned and investigated.Analysis at neuropace confirmed the device was in a high current state and was unresponsive to telemetry consistent with a reset.During analysis the device was intentionally returned to normal operation whereupon it met manufacturing acceptance criteria, indicating the device did not malfunction and was not damaged.

• 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: 8340932
• MDR Text Key: 136856807
• Report Number: 3004426659-2019-00005
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190821
• 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: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 26562-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR