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

Model Number RNS NEUROSTIMULATOR

Device Problem Leak/Splash (1354)

Patient Problems Bacterial Infection (1735); Itching Sensation (1943); Staphylococcus Aureus (2058); Discharge (2225); Post Operative Wound Infection (2446)

Event Date 05/26/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient was implanted with the rns system including a neurostimulator and two depth leads (dl-330-10-k).Depth leads were placed in the right and left hemisphere in mesial temporal structures.On (b)(6) 2015, dc leak reset was reported to product monitoring.The dc leak was triggered by a debridement procedure performed to address an incision site infection.Infection was reported as staph.There was clear discharge and itching which indicated there may be an infection present.Scalp incision infection, debrided on (b)(6) 2015, patient hospitalized from (b)(6) 2015.Scalp incision culture after 48 hours: positive for staph.Epidermidis, staph.Capitis treatment - 7 weeks of intravenous vancomycin no report of product malfunction.The rns neurostimulator and leads remain implanted.The rns system is programmed by the doctor for detection and treatment of epilepsy.

Manufacturer Narrative

(b)(4).The rns neurostimulator and leads remain implanted.The rns system is programmed by the doctor for detection and treatment of epilepsy (b)(4).Sterility record review performed.No evidence of factors that could have caused or contributed to the reported event.All sterilization results met requirements as specified in the specifications.Device remains implanted.

• 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: 4869047
• MDR Text Key: 16635773
• Report Number: 3004426659-2015-00003
• Device Sequence Number: 1
• Product Code: PFN
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2015

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: Physician
• Device Model Number: RNS NEUROSTIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 06/25/2015
• 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