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

Model Number RNS-320-K

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

Patient Problems Purulent Discharge (1812); Impaired Healing (2378); Drug Resistant Bacterial Infection (4553)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace for analysis.

Event Description

On (b)(6) 2020 the patient's rns neurostimulator was explanted to treat an incision site infection.The patient presented with delayed wound healing, purulent serosanguinous discharge, foul odor and scabbing.Treatment also included 2 weeks of antibiotics.

Event Description

The treating center provided neuropace additional information regarding the patient's status.

Manufacturer Narrative

(b)(4).As reported previously, the patient presented on (b)(6) 2020 with an infection at the rns system incision site resulting in explant of the rns neurostimulator.The rns system ferrule and leads remained implanted.The patient was aggressively treated with antibiotics and returned (b)(6) 2020, asymptomatic and afebrile.When the neurosurgeon cut into the incision site, pus was noted and therefore, the ferrule and both depths leads were explanted.The area was flushed with antibiotics and antibiotic powder was sprinkled throughout.The explanted product was not returned to neuropace for analysis.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 10575298
• MDR Text Key: 208191722
• Report Number: 3004426659-2020-00044
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200530
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 28451-1-1-1
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR