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 10/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial implant: the system consists of the rns neurostimulator, placed in the right parietal region, and two depth leads: port 1 dl-344, sn (b)(4), left mesial temporal, port 2, dl-330, sn (b)(4), right mesial temporal.

Event Description

On (b)(6) 2017 neuropace became aware that the patient's neurostimulator underwent a dc leak reset on (b)(6) 2017.The treating site was contacted in order to determine what had occurred.According to the treating site, on (b)(6) 2017 the patient stated their incision site was painful, draining and red.The patient then underwent a wound debridement (resulting in the neurostimulator dc leak) and was administered rifampin and doxycycline.The treating site reported this as a superficial incisional infection.The rns system remains implanted.At the time of the event the rns neurostimulator was programmed for detection only, stimulation had not been enabled.

• 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: 7088626
• MDR Text Key: 94056492
• Report Number: 3004426659-2017-00058
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017171102
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• 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: 23602-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• 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: 38 YR