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

Model Number DL-330-3.5

Device Problems Signal Artifact/Noise (1036); Break (1069); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The explanted lead was not returned to neuropace for analysis, however review of the lead impedance and ecog data was performed and the data is consistent with a lead break.Unable to determine root cause.Patient has a history of seizure related falls.

Event Description

The neuropace fce noted an ecog artifact on channel 1 of the depth lead connected to port 1 of the neurostimulator.The patient was being followed by two separate treating centers and both were notified of the issue.Channel 1 was turned off for sensing and stimulation on the affected lead.Discussion of a lead revision was started and was subsequently performed (b)(6) 2018.

• 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: 7497268
• MDR Text Key: 107689844
• Report Number: 3004426659-2018-00014
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: DL-330-3.5
• Device Catalogue Number: 1006204
• Device Lot Number: 14104-1-1-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/08/2018
• 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