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

Model Number CL-325-10

Device Problems Break (1069); Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace for investigation.Review of the lead impedance and ecog data was performed and the data is consistent with a lead break.Unable to determine root cause of the lead break.

Event Description

During a review of rns neurostimulator data by the treating clinician, artifact was observed on the ecog recorded from the left strip lead , indicating a potential lead break.After discussion with the patient, it was determined that this signal change occurred following a fall due to a seizure, consistent with the patient's pre-implant seizure semiology.The patient was subsequently scheduled for a lead replacement procedure, which was performed without complication.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, ca ; 2382788
• MDR Report Key: 10387984
• MDR Text Key: 202891742
• Report Number: 3004426659-2020-00026
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917210123
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CL-325-10
• Device Catalogue Number: 1007609
• Device Lot Number: 25330-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2020
• 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: 55 YR