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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 Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cerebrospinal Fluid Leakage (1772)
Date of Event 04/13/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).No indication of product failure.
 
Event or Problem Description
The patient presented with a headache on (b)(6) 2019, the day after implant with the rns system neurostimulator and leads.Fluid leakage was observed from the left burr hole cover incision site and was repaired by the center.The patient was brought back to the operating room on (b)(6) 2019 for removal of the lead and additional repair of the csf leak.Patient was discharged on (b)(6) 2019.No further details were 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 Key8599731
Report Number3004426659-2019-00016
Device Sequence Number14026990
Product Code PFN
UDI-Device Identifier00855547005045
UDI-Public010085554700504517220124
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P100026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/07/2019
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 NumberDL-330-10-K
Device Catalogue Number1007605
Device Lot Number27392-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/15/2019
Initial Report FDA Received Date05/10/2019
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 Other;
Patient Age21 YR
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