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

Model Number RNS-300M-K

Device Problem Insufficient Information (3190)

Patient Problem Skin Erosion (2075)

Event Date 05/28/2014

Event Type  Injury  

Event Description

The patient presented with a skin erosion.During surgery the erosion was determined to be overlying the ferrule tab that is adjacent to the connector cover.This tab was removed to lower the profile and the wound was closed.No implantable products were removed.

Manufacturer Narrative

Rns system was not explanted.

Manufacturer Narrative

Additional information received: on 03/18/2014 - erosion initially reported.Reference number (b)(4).On 07/09/2014 - product evaluation - investigation of the returned neurostimulator was performed.There was no evidence of neurostimulator failure.A review of sterility test reports and batch records was performed.All tests and reports passed.No evidence of product failure that could have caused or contributed to the reported event.

Event Description

Follow up 2 - product investigation results.

Manufacturer Narrative

On 03/18/2014 erosion initially reported.Reference number (b)(4).On (b)(6) 2014 patient had skin erosion.The patient was scheduled for surgery to revise the eroded area with the intention of cleaning and doing a scalp rotation procedure if possible; otherwise, they were going to explant.During patient preparation for surgery, while shaving and cleaning the incision area, it was determined that the top left corner of the connector cover was protruding out the eroded area.Because that corner was sticking out, dr davis decided to explant everything but the leads.Device has not been returned.

Event Description

Follow up 1.

• Brand Name: NEUROSTIMULATOR® RNS® SYSTEM
• Type of Device: NEUROSTIMULATOR® 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: 3753827
• MDR Text Key: 14881117
• Report Number: 3004426659-2014-00001
• 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,Followup,Followup
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• 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: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 42 DA