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

Model Number RNS-300M-K

Device Problems Electrical /Electronic Property Problem (1198); Impedance Problem (2950); Programming Issue (3014)

Patient Problem Pain (1994)

Event Date 09/28/2014

Event Type  Injury  

Event Description

Dr.(b)(6) reports patient experiences sharp shooting pain behind right eye for a split second when impedance measurement is performed.Dr.(b)(6) upon interrogation of patient's neurostimulator noted that patient experienced a sharp shooting pain behind right eye for a brief period of time.Dr.(b)(6) was able to reproduce this with subsequent interrogations.It was determined that during interrogation of the neurostimulator impedance measurements are checked by the neurostimulator.During impedance measurements a current of 3mamp is delivered.Neurostimulator cannot be programmed to deliver impedance measurements at a lower current.Mitigation: when neurostimulator is interrogated a magnet will be placed between neurostimulator and telemetry wand.This will disable the neurostimulator from delivering current to check impedance measurements.There is no indication that the product malfunctioned.The rns system remains implanted in the patient.The rns system is programmed for detection and delivery of therapy as designed.

Manufacturer Narrative

Reference number (b)(4).No product to be returned.

• 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: 4194731
• MDR Text Key: 4967027
• Report Number: 3004426659-2014-00014
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RNS-300M-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 40 YR