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 02/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This was an initial implant, the patient was implanted with vns previously, no invasive monitoring, was performed leads were secured with dog bones, skin closure with sutures.Vancomycin powder was used.Two depth leads :(sn (b)(4), port 1, right hippocampus, mesial temporal) and (sn (b)(4), port 2 port2, left post temporal, non mesial) device not returned to manufacturer.

Event Description

Patient was admitted for wound cleaning for a possible infection.All three incisions (2 depth lead insertion sites and the device) had areas were the incision line was slightly open.They opened all incision lines.The device skin flap and wound was cleansed with peroxide, then betadine followed by antibiotic irrigation/flush.They used a plasma blade to dissect the skin edges and sutured the wound closed using nylon sutures after vancomycin powder was applied to the wound.They did obtain a swab of the incision site for culture when they first opened the incision site.The rns system and leads were intact, and were never disconnected, moved or handled and had normal battery voltage, lead impedances and real-time ecog readings upon interrogation prior to the start of the procedure.The neurostimulator continued to have normal impedance readings and ecog tracings when interrogated at neurostimulator incision closure and again at the end of the procedure after the dressings were in place.

• 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: 6371779
• MDR Text Key: 68779734
• Report Number: 3004426659-2017-00009
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170608
• 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: Physician
• Type of Report: Initial
• Report Date: 02/28/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 03/02/2017
• 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: 31 YR