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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-325-10-K
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Headache (1880); Intracranial Hemorrhage (1891); Speech Disorder (4415)
Date of Event 01/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).The rns system remains implanted and programmed for use.
 
Event or Problem Description
On (b)(6) 2021 the patient presented with severe headaches and speech difficulty which had started two days earlier.A brain mri was performed which identified a left parietal intracerebral hemorrhage located below of the site of the rns system leads).Diagnosed as an acute cerebral hemorrhage.Treatment included prolonged hospitalization.
 
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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 Key11280640
Report Number3004426659-2021-00002
Device Sequence Number2590631
Product Code PFN
UDI-Device Identifier00855547005069
UDI-Public010085554700506917210507
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P100026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/04/2021
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-325-10-K
Device Catalogue Number1007609
Device Lot Number25987-1-1-1
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/11/2021
Initial Report FDA Received Date02/04/2021
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 Age27 YR
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