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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 Codes Head Injury (1879); Injury (2348)
Date of Event 06/12/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).As it was a recent implant the device was programmed for detection only and therapy was not yet enabled.
 
Event or Problem Description
The patient crashed his atv on (b)(6) 2018; as a result his incision opened exposing the rns neurostimulator.Antibiotics were administered by the emergency room and the patient was referred to neurosurgery.The rns neurostimulator and leads were explanted on (b)(6) 2018.No infection was suspected; however cultures were taken and results are pending.
 
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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 Key7687449
Report Number3004426659-2018-00021
Device Sequence Number19161431
Product Code PFN
UDI-Device Identifier00855547005120
UDI-Public010085554700512017181115
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 Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/11/2018
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 Number25453-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/13/2018
Initial Report FDA Received Date07/13/2018
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 Age51 YR
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