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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 CL-335-10-K
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event 12/17/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).The rns system remains implanted and programmed for use.
 
Event or Problem Description
The patient underwent initial placement of the rns system on (b)(6) 2019.Post-op, a routine ct scan was performed, which identified a hemorrhage around the left temporal cortical strip lead.The left cortical strip lead was subsequently explanted on (b)(6) 2019, and all other leads remained implanted.No other details were 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 Key9595938
Report Number3004426659-2019-00068
Device Sequence Number3174880
Product Code PFN
UDI-Device Identifier00855547005052
UDI-Public010085554700505217200209
Combination Product (Y/N)N
Initial Reporter StateMA
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
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/14/2020
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 NumberCL-335-10-K
Device Catalogue Number1007610
Device Lot Number23365-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/20/2019
Initial Report FDA Received Date01/16/2020
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 Other;
Patient Age53 YR
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