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

Model Number RNS-300M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Impaired Healing (2378); Device Embedded In Tissue or Plaque (3165)

Event Date 05/22/2014

Event Type  Injury  

Event Description

Patient reported wound healing issues approximately a month after replacement implant.Neurosurgeon removed neurostimulator and ferrule.Strips remain implanted.(b)(6) 2014 patient notified site that she was having wound healing issues.Site instructed patient to see local md.(b)(6) 2014 np was contacted by site stating patient was going to be seen by ns for wound issue.Aware date (b)(6) 2014 patient was seen by site (ns) and decision was made to explant rns.(b)(6) 2014 patient taken to surgery; rns and ferrule explanted; cultures taken and sent to pathology.Leads remain in place and were capped; sutures placed for identification purposes.(b)(6) 2014 the fce reported that the patient had erosion at the wound site.

Manufacturer Narrative

(b)(4).The device was returned to neuropace for investigation and decontamination.The device wa successfully interrogated and the data synchronized.The product performed as expected.No fault found.

• 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: 3839501
• MDR Text Key: 15326761
• Report Number: 3004426659-2014-00003
• 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: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• 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: 05/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• 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: 27