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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-344-3.5-K
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Bacterial Infection (1735)
Date of Event 08/30/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).The rns system remains implanted and programmed for use.
 
Event or Problem Description
(b)(6) 2021: the patient presented with scab like healing around the incision site including incision drainage.This was reported as an on-going infection reported to be superficial and in the tissue around the leads the patient was sent to post-anesthesia care unit (pacu) for a vacuum-assisted wound closure.Diagnosed as a superficial and deep incisional infection.
 
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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 Key12483360
Report Number3004426659-2021-00046
Device Sequence Number3736912
Product Code PFN
UDI-Device Identifier00855547005021
UDI-Public010085554700502117220729
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 Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 09/15/2021
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-344-3.5-K
Device Catalogue Number1007606
Device Lot Number28514-1-1-1
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/30/2021
Initial Report FDA Received Date09/16/2021
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 Age40 YR
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