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 Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2016 patient underwent his fifth routine surgery for battery replacement.At the time, the patient was implanted with three leads (2 depths and 1 strip).

Event Description

Neuropace was informed on (b)(6) 2017 that the patient had reported that he had fluid around the neurostimulator on (b)(6) 2017.No action was taken at that time.The patient was seen on (b)(6) 2017 and responsive stimulation was disabled on the neurostimulator, however detection remained enabled.Details regarding the reason for the programming change were not provided.On (b)(6) 2017, the rns neurostimulator was explanted to treat infection.No other details regarding the event have been provided by the center.

Manufacturer Narrative

(b)(4).The patient underwent a routine neurostimulator replacement in (b)(6) 2016.In (b)(6) 2016 the patient developed irritation along the incision scar, however the patient did not report this irritation to the treating center until (b)(6) 2017.When seen by the treating center in (b)(6) 2017, the patient was found to have dehiscence of the incision site resulting in exposed hardware (lead and rns neurostimulator).The patient refused antibiotic treatment for a presumed propionibacterium infection.The site presented the patient with an option of attempted scar revision (with retention of hardware) or explantation.The patient/family opted for explantation.The explant (neurostimulator and all leads) was performed on (b)(6) 2017.Treatment included a short course (2 weeks) of postoperative antibiotics, for presumed propionibacterium acnes infection as culture results were negative.Wound remained healed after antibiotic treatment was finished.

• 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: 6897880
• MDR Text Key: 87522621
• Report Number: 3004426659-2017-00044
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017160902
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007603
• Device Lot Number: 21647-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• 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: 44 YR