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

Model Number CL-335-10-K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lead was not returned to neuropace.There was no indication of product failure.In addition, the lead was discarded at the time of explant by the treating center.

Event Description

On (b)(6) 2019 the treating center noted that the end of the neuropace strip lead, implanted the day prior, was protruding through the incision site.The lead had been implanted during the completion of phase ii monitoring and had been capped with a lead cap.The surgeon explanted the lead and replaced it with a new lead.

• 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: 8570094
• MDR Text Key: 143723204
• Report Number: 3004426659-2019-00015
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005052
• UDI-Public: 010085554700505217210628
• 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: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CL-335-10-K
• Device Catalogue Number: 1007610
• Device Lot Number: 26294-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2019
• 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): Other
• Patient Age: 41 YR