MAUDE Adverse Event Report: NEUROPACE INC. NEUROPACE FERRULE KIT; NEUROPACE RNS SYSTEM

Model Number F-01-K

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 01/10/2017

Event Type  Injury  

Event Description

During implantation of rns generator, it was noted by surgeon (b)(6) that the screws that were to be used to hold the rns generator in place were "not catching." at this time, neuropace representative (b)(4) was notified of the situation.A separate kit was opened which included the necessary items needed to secure the generator.The faulty items and screws were removed from the field, placed in a biohazard bag and a patient label was placed on the bag.Manager (b)(4) notified of the event.

• Brand Name: NEUROPACE FERRULE KIT
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE INC.; 455 n. bernardo ave; mountain view CA 94043
• MDR Report Key: 6303515
• MDR Text Key: 66726190
• Report Number: MW5067670
• Device Sequence Number: 1
• Product Code: PFN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2017

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: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: F-01-K
• Device Catalogue Number: F-01-K
• Device Lot Number: 21412-1-1-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR