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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-344-10-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 12/06/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4), the explanted product was not returned to neuropace for analysis.
 
Event or Problem Description
During the beginning of the patient's initial (b)(6) system placement, the neurosurgeon inserted a cannula as part of the standard neurosurgical process to implant a neuropace depth lead.The neurosurgeon noted blood in the cannula during the lead implantation process and subsequently halted the procedure.The cannula was removed and the patient was taken for imaging.Per the neurosurgeon, the cannula may have punctured a blood vessel during initial placement.Additional information was not 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 Key9531847
Report Number3004426659-2019-00064
Device Sequence Number11457519
Product Code PFN
UDI-Device Identifier00855547005014
UDI-Public010085554700501417220724
Combination Product (Y/N)N
Initial Reporter StateSC
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
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/30/2019
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-344-10-K
Device Catalogue Number1007607
Device Lot Number28457-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/06/2019
Initial Report FDA Received Date12/30/2019
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 Hospitalization; Other;
Patient Age44 YR
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