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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-300M
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/12/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).This was the patient's first rns system implant.
 
Event or Problem Description
The neurosurgeon reported that the patient had a pin-hole sized opening along the incision.The patient was taken to the or on the night of (b)(6) 2018 for cleaning of the infected area.The infection was determined to be more significant than anticipated and the patient was scheduled for explant of the rns system.The neurostimulator and all leads were explanted on (b)(6) 2018.The infection was categorized by the treating site as deep incisional.
 
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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 Key7645795
Report Number3004426659-2018-00018
Device Sequence Number13865933
Product Code PFN
UDI-Device Identifier00855547005120
UDI-Public010085554700512017181205
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P100026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/27/2018
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 Physician
Device Model NumberRNS-300M
Device Catalogue Number1007910
Device Lot Number25657-1-1-1
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/12/2018
Initial Report FDA Received Date06/28/2018
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; Required Intervention;
Patient Age54 YR
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