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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 DL-330-10-K
Medical Device Problem Codes Signal Artifact/Noise (1036); High impedance (1291)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/25/2026
Type of Reportable Event Malfunction
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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
Manufacturer (Section G)
NEUROPACE, INC.
455 n. bernardo ave.
mountain view CA 94043
Manufacturer Contact
ramona gonis
455 n. bernardo ave.
mountain view, CA 94043
5108822607
MDR Report Key25813524
Report Number3004426659-2026-00071
Device Sequence Number6038135
Product Code PFN
UDI-Device Identifier00855547005335
UDI-Public010085554700533517270318
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 Year2024
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional,Company Representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/14/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberDL-330-10-K
Device Catalogue Number1007929
Device Lot Number34166-1-1-1
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/25/2026
Initial Report FDA Received Date07/14/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Other;
Patient Age20 YR
Patient SexMale
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