MAUDE Adverse Event Report: NEUROPACE,INC NEUROPACE RNS SYSTEM

Model Number RNS-300M-K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is the patient's 5th neurostimulator.The patient's system consisted of the rns neurostimulator and two leads: port 1, cl- sn (b)(4), left temporal subdural and port 2, dl -sn (b)(4), left mesial temporal.

Event Description

The patient's rns neurostimulator and leads were explanted in response to an implant site infection.The details of the infection nor the procedure have not been provided by the treating center.

• 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 ; 6502372788
• MDR Report Key: 6996138
• MDR Text Key: 90871739
• Report Number: 3004426659-2017-00049
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170523
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007603
• Device Lot Number: 22812-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2017
• 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; Required Intervention
• Patient Age: 48 YR