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

Model Number RNS-300M-K

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 06/19/2014

Event Type  Injury  

Event Description

The patient has been returning to the clinic post surgery to have his incision checked.The incision has not healed well with signs of infection.The neurosurgeon elected to explant the entire system.Complete system explant due to infection.

Manufacturer Narrative

(b)(4).Investigation of the returned explanted leads and neurostimulator was performed.There was no evidence of neurostimulator nor lead failure.Performed review of sterility test reports and batch records.All tests and reports passed.No evidence of factors that could have caused or contributed to the reported event (infection).

• 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: 3923872
• MDR Text Key: 4521571
• Report Number: 3004426659-2014-00004
• 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: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: RNS-300M-K
• Device Catalogue Number: RNS-300M-K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2014
• 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: 25