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 Bacterial Infection (1735); Discharge (2225); Fluid Discharge (2686)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The rns remains implanted and programmed for use.

Event Description

Patient underwent a routine device replacement due to expected battery depletion and elective repositioning of the right lead on (b)(6) 2019.During the same procedure, a concurrent resection was also performed.On (b)(6) 2019 it was reported that the patient was experiencing drainage from the incision site which required the application of a new bandage the patient was placed on a 6 week antibiotic treatment.

• 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: 9577382
• MDR Text Key: 187169686
• Report Number: 3004426659-2019-00067
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200506
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• 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: 28416-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2019
• 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
• Patient Age: 48 YR