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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM
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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 Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event 04/18/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Note - this report was originally reported incorrectly as 3004426659-2019-00026.The correct mfr number should be 3004426659-2019-00023.
 
Event or Problem Description
The patient underwent rns system placement on (b)(6) 2019.On (b)(6) 2019, the treating center performed a debridement and irrigation of the infected incision site.On (b)(6) 2019, the rns neurostimulator and leads were explanted.Additional details were not provided by the treating center.
 
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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 Key8712159
Report Number3004426659-2019-00023
Device Sequence Number2663581
Product Code PFN
UDI-Device Identifier00855547005120
UDI-Public010085554700512017191017
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
P100026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/29/2019
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 Number27434-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/17/2019
Initial Report FDA Received Date06/19/2019
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 Hospitalization; Other;
Patient Age26 YR
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