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

Model Number DL-344-10-K

Device Problems Break (1069); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The ecog and impedance data are suggestive of a potential lead break.Neuropace was unable to determine a root cause.The explanted product was not returned to neuropace, inc.

Event Description

On (b)(6) 2017 a signal artifact was observed on the left depth lead indicating a potential lead break.On (b)(6) 2017 a lead revision was performed and the depth lead with the signal artifact was explanted and a new lead was implanted.The explanted lead was not returned to neuropace for investigation.The patient does occasionally fall during seizures but the treating center was unable to determine if this was the cause of the possible break.

• 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: 7791583
• MDR Text Key: 117419596
• Report Number: 3004426659-2018-00037
• 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: Physician
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DL-344-10-K
• Device Catalogue Number: 1007440
• Device Lot Number: 18860-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• 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: 36 YR