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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 Impaired Healing (2378)
Date of Event 05/09/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).The burr hole cover is not a neuropace product.
 
Event or Problem Description
The patient reported irritation at the right-sided burr hole cover (a non-neuropace product) incision site.After review by the treating center, it was determined that the incision site had not healed properly.The neurosurgeon exposed the non-neuropace burr hole cover and found that two of the screws had come loose.The two loose screws were removed and the cover remains secured by calcification and the remaining screw.The event resolved following the surgery.
 
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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 Key8666609
Report Number3004426659-2019-00022
Device Sequence Number2268846
Product Code PFN
UDI-Device Identifier00855547005045
UDI-Public010085554700504517210507
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 Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/03/2019
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 Number25985-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/09/2019
Initial Report FDA Received Date06/04/2019
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; Required Intervention;
Patient Age39 YR
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