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

Model Number CL-325-10-K

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

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

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lead migration is a potential risk as indicated in the rns® system physician manual.As indicated in the approved labeling, "the implanted lead(s) may migrate from their desired implant location.Lead migration can result in changes in detections and stimulation effectiveness, and may require additional surgical procedures to modify the lead location.".

Event Description

The patient underwent rns system placement on (b)(6) 2019.It was communicated to neuropace that the cortical strip placement was impeded during the procedure due to the stereotactic frame placement.Two ct scans were performed post-procedure and comparison of the scans indicated that the unconnected strip lead had migrated.The patient was brought back to the or for lead repositioning.No further information was provided by the treating center.

• 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: 9252349
• MDR Text Key: 178736215
• Report Number: 3004426659-2019-00049
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917210717
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CL-325-10-K
• Device Catalogue Number: 1007609
• Device Lot Number: 26319-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2019
• 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: 47 YR