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

Model Number 1007603

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

Patient Problems Bacterial Infection (1735); Erosion (1750)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Not returned.

Event Description

On (b)(6) 2015- patient was implanted with the rns system including neurostimulator (sn (b)(4)) and four cortical strip leads (sn (b)(4)).On 06/28/2016 the site reported that the patient had an exposed neuropace neurostimulator in left temporal aspect, skin defect approximately 2 cm with purulent drainage and fluctuance.Treatment included: hospitalization, ct scan, cefepime 2g every 8 hrs., vancomycin 1500mg, on (b)(6) 2016 -vancomycin 1.25g every 12 hours.On (b)(6) 2016 -the patient presented to the operating room.The rns neurostimulator incision had erosion approximately 2 cm long with a gap of 1 cm in width.It was noted that the prior incision was over the neurostimulator (not over cranial bone).The attending surgeon decided to remove the neurostimulator and all four implanted leads due to infection risk.There were no acute complications during the explant procedure.No indication of product failure.Product has been implanted for greater than 230 days.

• 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: 5790231
• MDR Text Key: 49411258
• Report Number: 3004426659-2016-00018
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017151203
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2016

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: Physician
• Device Model Number: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/13/2016
• 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: 46 YR