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 11/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial implant: system consists of the rns neurostimulator and four leads: port 1, dl-344, sn (b)(4), left lateral temporal node.Port 2, dl-344, sn (b)(4), left mesial temporal posterior periventricular node.Not connected, dl-330, sn (b)(4), left mesial temporal, anterior peri node.Not connected, dl-344, sn (b)(4), left mesial temporal hippocampus.

Event Description

Neuropace was notified on 11/7/2017 that the patient had been explanted due to infection.Further information provided by the site clarified that the patient had noticed increasing drainage from wound for 2 weeks prior to coming to the emergency department on (b)(6) 2017.Frank purulent drainage was expressed from two areas on the right scalp.The patient stated that he had not showered since his surgery in (b)(6).The patient was taken to the operating room on (b)(6) 2017 for explant of the rns neurostimulator and leads.Antibiotic treatment consisted of vancomycin, nafzil, and cefazolin.The site described the infection as a superficial and deep incisional infection.

• 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: 7095445
• MDR Text Key: 94132798
• Report Number: 3004426659-2017-00057
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017171223
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• 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: 1007910
• Device Lot Number: 23821-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2017
• 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