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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 Codes Signal Artifact/Noise (1036); Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The explanted lead was not returned to neuropace for analysis.However, review of the device ecog and lead impedance confirmed that the ecog data are suggestive of a potential lead break.
 
Event or Problem Description
On (b)(6) 2019, intermittent artifact was identified through ecog review, suggestive of a possible lead break in the left depth lead connected to port 2.Further review of the lead impedance and ecog data was performed and was consistent with a lead break.During a routine rns neurostimulator replacement procedure, the lead was explanted and a new lead was implanted and connected to port 2.
 
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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 Key9501373
Report Number3004426659-2019-00062
Device Sequence Number1305086
Product Code PFN
UDI-Device Identifier00855547005045
UDI-Public010085554700504517210606
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
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberDL-330-10-K
Device Catalogue Number1007605
Device Lot Number26124-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/21/2019
Initial Report FDA Received Date12/20/2019
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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