Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NEUROPACE, INC. NEUROPACE RNS SYSTEM Back to Search Results
Model Number RNS-300-K
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Wound Dehiscence (1154); Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event 01/24/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace.
 
Event or Problem Description
On (b)(6) 2019, the patient's rns neurostimulator and all leads were explanted to treat an infection.No further details were provided by the treating center.
 
Additional Manufacturer Narrative
(b)(4).12/2018 patient presented with dehiscence of the incision site.The rns system ( rns device and two leads) were explanted and the patient was placed on a 4 week picc antibiotic treatment.
 
Event or Problem Description
Additional details provided by treating center.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEUROPACE RNS SYSTEM
Common Device Name
NEUROPACE RNS SYSTEM
Manufacturer (Section D)
NEUROPACE, INC.
455 n. bernardo ave.
mountain view CA 94043
MDR Report Key8354686
Report Number3004426659-2019-00004
Device Sequence Number1606502
Product Code PFN
UDI-Device Identifier00855547005120
UDI-Public010085554700512017181115
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
P100026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/07/2019
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
Operator of Device No Information
Device Model NumberRNS-300-K
Device Catalogue Number1007910
Device Lot Number25453-1-1-1
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/24/2019
Supplement Date Received by Manufacturer02/27/2019
Initial Report FDA Received Date02/20/2019
Supplement Report FDA Received Date03/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age19 YR
-
-