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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 Seizures (2063)
Date of Event 07/28/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The patient was admitted to the treating center's epilepsy monitoring unit on (b)(6) 2018 in possible status epilepticus.The patient remains in status as of (b)(6) 2018.The patient underwent a combined resection as well as a rns neurostimulator and cortical strip implantation procedure on (b)(6) 2018.The on-call epileptologist stated that she cannot rule out the possibility that this is related to the procedure performed on (b)(6) 2018 which included a resection.Stimulation was enabled on (b)(6) 2018 in an effort to see if the patient would benefit from therapy.
 
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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 Key7828155
Report Number3004426659-2018-00031
Device Sequence Number13774684
Product Code PFN
UDI-Device Identifier00855547005120
UDI-Public010085554700512017181205
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 Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/29/2018
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 Number1007910
Device Lot Number25657-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/01/2018
Initial Report FDA Received Date08/29/2018
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;
Patient Age64 YR
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