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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 Code Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event 08/31/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient has a history of seizing and falling as well as balance issues.
 
Event or Problem Description
The patient was admitted to memorial hermann neurosurgery today for explant of the entire rns system due to hemorrhage at the rns lead site.The patient reported headaches before going to the hospital.No additional details have been 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 Key7920912
Report Number3004426659-2018-00038
Device Sequence Number13815244
Product Code PFN
UDI-Device Identifier00855547005120
UDI-Public010085554700512017170608
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P100026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/28/2018
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 No Information
Device Model NumberRNS-300M-K
Device Catalogue Number1007603
Device Lot Number22882-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/31/2018
Initial Report FDA Received Date09/28/2018
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; Required Intervention;
Patient Age19 YR
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