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

Model Number RNS-320-K

Device Problem Failure to Interrogate (1332)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The explanted neurostimulator was returned to neuropace for analysis.Neuropace investigation results: the neurostimulator entered a high current state after being implanted and was unresponsive to telemetry.The device was confirmed to have been exposed to electrocautery which is the most probable cause of the reset.Analysis confirmed there was no device damage.Additional testing confirmed that the device passed all manufacturing acceptance criteria.

Event Description

The neurostimulator was implanted and was functioning as intended.After surgical closure of the neurostimulator implantation site, at the discretion of the neurosurgeon the wound was re-opened and subsequently closed.Testing performed on the neurostimulator after final closure was not successful and the device would not interrogate.After unsuccessful troubleshooting, the patient returned to the operating room where the neurostimulator was removed and a new neurostimulator was placed into the ferrule.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043
• MDR Report Key: 7791585
• MDR Text Key: 117420273
• Report Number: 3004426659-2018-00025
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190326
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 25875-1-1-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR