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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 Break (1069); High impedance (1291)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/18/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4) review of the device ecog and lead impedance confirmed that the ecog data are suggestive of a potential lead break.
 
Event or Problem Description
A change in the signals for the depth lead connected to port 1 of the rns neurostimulator was noticed on (b)(6) 2017.The treating center reported that the patient had a post-ictal altercation on (b)(6) 2017 in which the patient's head hit the ground.On (b)(6) 2018, detection was disabled on the depth lead connected to port 1.During a routine neurostimulator replacement on (b)(6) 2019, the lead was removed and a new lead was implanted and connected to the neurostimulator without complications.
 
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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 Key8417451
Report Number3004426659-2019-00007
Device Sequence Number1473605
Product Code PFN
UDI-Device Identifier00855547005045
UDI-Public010085554700504517200508
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P100026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/13/2019
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 Number23840-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/18/2019
Initial Report FDA Received Date03/13/2019
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 Age31 YR
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