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

Model Number RNS NEUROSTIMULATOR

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Headache (1880); Pain (1994); Staphylococcus Aureus (2058)

Event Date 07/06/2015

Event Type  Injury  

Event Description

(b)(6) 2015: patient implanted with neuropace rns neurostimulator and two neuropace depth leads (dl-330-3.5k) (b)(6) 2015: the rns neurostimulator detection was enabled (b)(6) 2015: the rns neurostimulator and neuropace depth leads were explanted due to signs of infection.The infection was described as beginning 2 weeks prior to the explant date.The patient began to have daily headache and tenderness along the vertex portion of her incision that worsened daily despite increasing pain control with percocet po.The patient denied fever or drainage from the incision site.(b)(6) from blood cultures taken upon admission and (b)(6) detected from wound culture taken during the explant procedure.Patient is being followed by infectious disease with a treatment plan of iv nafcillin 2 grams q 4 hours for at least 4 weeks.

Manufacturer Narrative

(b)(4).Sterility record review performed.Sterilization results met requirements as specified in the specifications.No evidence of factors that could have caused or contributed to the reported event.All sterilization results met requirements as specified in the specifications.Product not returned.

• 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: 4968671
• MDR Text Key: 6073929
• Report Number: 3004426659-2015-00013
• 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: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• 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
• Date Manufacturer Received: 07/06/2015
• 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: 39 YR