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

Model Number DL-330-10-K

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Event Description

The treating center identified unusual waveforms on lead 2 during a patient ecog review.Evidence of a lead fracture was first apparent on (b)(6) 2021.During the neuropace investigation of the ecog data, we observed unusual waveforms, indicative of a lead break.The lead was explanted and replaced on (b)(6) 2021.The lead was secured with a dog bone and lead protector.Lead was implanted for 0.2 years.There was no identified cause of the lead break.

Manufacturer Narrative

(b)(4).The explanted device was not returned to neuropace for investigation.

• 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: 15270881
• MDR Text Key: 305427462
• Report Number: 3004426659-2022-00029
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005335
• UDI-Public: 010085554700533517240513
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007929
• Device Lot Number: 31246-1-1-1
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 08/22/2022
• 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: 28 YR
• Patient Sex: Female