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

Model Number RNS-300M-K - FGI, PMA, RNS NEUROSTIMULATOR

Device Problem Battery Problem (2885)

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

Event Date 09/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The rns reset to inactive mode when the battery reached end of life after being implanted for approximately 2 years.The rns was explanted on (b)(6) 2016 and returned to neuropace for analysis.Neuropace is currently investigating the returned device.The patient received a replacement device on (b)(6) 2016.

Manufacturer Narrative

(b)(4).No fault found.Upon receipt the device responded correctly to telemetry and the reported battery voltage was consistent with what was measured once the device was opened.The current drain in each of the 6 programmed settings that were used during implant was measured on the bench.The results matched expected results for a well-functioning device.An estimate of the battery capacity spent was made based on the diagnostic data available from the device.The diagnostic data is necessarily incomplete due to memory limitations of the implant so the result is a very rough estimate.The results were not conclusive but were consistent with a high detection rate resulting in a heavy therapy load causing the observed battery depletion.The implant battery was returned to the manufacturer, (b)(4), for destructive analysis.(b)(4) conducted a thorough investigation and found no anomalies.The most probable cause for this battery depletion is the high therapy load caused by a high detection rate.

Event Description

New information provided in investigation of returned device completed.

• 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 ; 6502382788
• MDR Report Key: 5983253
• MDR Text Key: 55812521
• Report Number: 3004426659-2016-00024
• Device Sequence Number: 1
• Product Code: PFN
• 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
• Reporter Occupation: Device Unattended
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: RNS-300M-K - FGI, PMA, RNS NEUROSTIMULATOR
• Device Catalogue Number: 1007427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: 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: 24 YR