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

Model Number	CL-335-10-K
Medical Device Problem Codes	Break (1069); High impedance (1291)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Additional 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.The leads were placed during a preliminary procedure (prior to the implant of the rns) without a neuropace representative present.The case registration information, including the exact location of the leads by sn, was not comprehensively provided as requested on the form.As such, while the port connections are known, the precise serial number of the lead at this particular anatomical location with the abnormal impendence can only be identified as being right temporal.("insufficient charge was detected for electrodes r1, r2, r3, and r4").
Event or Problem Description
The lead was replaced on (b)(6) 2018 as the reading indicated a probable lead fracture.The site was not sure it was a lead break; he just knew the readings appeared off so we assume it was a nicked.The doctor did not want it to be evaluated.The doctor felt it was probably nicked by a resident when it was implanted.He suspected a hairline fracture.The x-ray showed everything was intact the neurosurgeon was hesitant to replace because he thought it could have been physiological.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 7853749
• Report Number: 3004426659-2018-00035
• Device Sequence Number: 19167164
• Product Code: PFN
• UDI-Device Identifier: 00855547005052
• UDI-Public: 010085554700505217181111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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
• Operator of Device: No Information
• Device Model Number: CL-335-10-K
• Device Catalogue Number: 1007610
• Device Lot Number: 21430-1-1-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 26 YR