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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-K
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event 10/04/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
 
Event or Problem Description
Neuropace was informed on 10/2/2019, that the patient's craniotomy incision site had dehisced, exposing the neurostimulator.The patient was scheduled for wound washout and device replacement on (b)(6) 2019.During surgery, the ferrule was also removed and a new ferrule was implanted.No further information was provided by the treating center.
 
Additional Manufacturer Narrative
(b)(4).No additional details were provided by the treating center.
 
Event or Problem Description
Culture results were provided by the physician.
 
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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 Key9267111
Report Number3004426659-2019-00051
Device Sequence Number1927499
Product Code PFN
UDI-Device Identifier00855547005120
UDI-Public010085554700512017170615
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
P100026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/01/2019
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-300M-K
Device Catalogue Number1007603
Device Lot Number22888-1-1-1
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/04/2019
Supplement Date Received by Manufacturer11/21/2019
Initial Report FDA Received Date11/01/2019
Supplement Report FDA Received Date12/20/2019
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;
Patient Age33 YR
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