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

Model Number CL-335-10-K

Device Problems Break (1069); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

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.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 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
• 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: 7853749
• MDR Text Key: 119489227
• Report Number: 3004426659-2018-00035
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005052
• UDI-Public: 010085554700505217181111
• 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: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/06/2018
• 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: 26 YR