MAUDE Adverse Event Report: NEUROPACE,INC NEUROPACE RNS SYSTEM

Model Number DL-344-10

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The ecog and impedance data are suggestive of a potential lead break.The explanted lead and rns neurostimulator were returned for evaluation.There was no fault found with the neurostimulator.The lead was received cut and damaged.Neuropace was unable to conclusively identify if a lead failure had occurred while implanted in a patient.The damage observed appears to be a result of the explant process and the use of a dog bone or similar securing mechanism.

Event Description

The site reported a possible lead break of the right hippocampal depth.Signal artifact was first observed on (b)(6) 2015 on the right hippocampal depth lead.The artifact was confirmed with real-time ecog during palpitation of the lead through the skin on (b)(6) 2016.Revision surgery (the lead was explanted and a new lead implanted) was performed on (b)(6) 2017 in conjunction with a routine neurostimulator battery replacement.

• 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 ; 6502372788
• MDR Report Key: 7040873
• MDR Text Key: 93178203
• Report Number: 3004426659-2017-00053
• 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: Other
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DL-344-10
• Device Catalogue Number: 1006197
• Device Lot Number: 13745-1-1-7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention
• Patient Age: 54 YR