MAUDE Adverse Event Report: NEUROPACE,INC NEUROPACE RNS SYSTEM

Model Number RNS-300M-K

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

Patient Problem Unspecified Infection (1930)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The rns system included the neurostimulator and two depth leads, dl-344-10.Port1, sn (b)(4), left mesial temporal.Port2, sn (b)(4), right mesial temporal.

Event Description

On 8/3/2017, neuropace was informed that the patient was diagnosed with an infection at the rns neurostimulator incision site on (b)(6) 2017.The patient's parents are unsure about the exact onset of the infection; however they believe it was 6 months ago due to a fall when the patient hit his head on the area that is now weeping and infected.The patient's mother had the local neurologist and pcp look at the wound, but did not contact the implanting neurosurgeon's office about the potential infection.When the patient was seen by the neurosurgeon on (b)(6) 2017 to discuss a routine neurostimulator battery replacement , the physician noticed the infected incision area.At that time, the patient reported associated discomfort at the incision site and was instructed to take bactrim ds 800 mg bid for 3 weeks and return to clinic for reassessment.

Manufacturer Narrative

(b)(4).The neurostimulator was explanted on (b)(6) 2017 and both depth leads were explanted on (b)(6) 2017 in response to the infection.Post explant the patient was placed on avycaz iv therapy for 6 weeks.The infection was categorized by the (b)(6) center as deep incisional, subdural.

• 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 ; 6502372788
• MDR Report Key: 6817285
• MDR Text Key: 83517045
• Report Number: 3004426659-2017-00040
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017151012
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

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: RNS-300M-K
• Device Catalogue Number: 1007603
• Device Lot Number: 19824-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 09/01/2017
• Supplement Dates FDA Received: 09/27/2017
• 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: 38 YR