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

Model Number RNS-300M

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

Patient Problems Tissue Damage (2104); Fluid Discharge (2686)

Event Date 05/14/2014

Event Type  Injury  

Event Description

Patient described a small circular opening over the implanted neurostimulator.Patient described a small amount of clear fluid drainage.Patient had revision of implant in (b)(6) of 2014 for similar opening.Patient was brought to the operating room on (b)(6) 2014 and revision/replacement of ferrule and neurostimulator was performed.The small opening was directly over the upper strain relief.

Manufacturer Narrative

(b)(4).The device was returned to neuropace for investigation and decontamination.The device was successfully interrogated and the data synchronized.The product performed as expected.No fault found.(b)(4) 2014 fce reported on patient infection " as of yesterday cultures are negative for the patient.No growth seen.".

• Brand Name: RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo avenue; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo avenue; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave; mountain view, CA 94043 ; 6502372388
• MDR Report Key: 3839498
• MDR Text Key: 15182372
• Report Number: 3004426659-2014-00002
• 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: 05/22/2014

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: Other
• Device Model Number: RNS-300M
• Device Catalogue Number: RNS-300M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61