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

Model Number DL-330-10-K

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the patient ecog and impedance data was consistent with a potential lead break.

Event Description

In early (b)(6) 2017, a suspected lead break was diagnosed by the treating epileptologist.Impedance measurements displayed "insufficient charge" on lead 2.There was no change in therapy.No information was provided by the treating center whether the patient had undergone any head trauma in the area of the lead exiting the skull.On (b)(6) 2017 the affected lead was replaced as it had continued to show high impedances.During the procedure the neurosurgeon did not observe any visible abnormalities at the lead-connector cover interface or at the skull entry point where the lead was anchored with a cut lead cap and a dog bone.The newly implanted depth lead showed good impedances and normal ecog readings, and the lead issue was considered resolved.The explanted lead has not yet been returned to neuropace, inc.

Manufacturer Narrative

(b)(4).The explanted lead was returned for investigation.Lead coil damage was confirmed; however neuropace was unable to determine the root cause.

Event Description

Product evaluation performed on returned product.

• 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: 7087519
• MDR Text Key: 93873159
• Report Number: 3004426659-2017-00055
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517190503
• 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,Followup
• Report Date: 07/12/2018

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: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 22147-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 07/12/2018
• 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
• Patient Age: 25 YR