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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 CL-335-10-K
Medical Device Problem Codes Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).The patient did not have the rns neurostimulator implanted therefore the leads were inactive.Explanted leads included: cl-335-10-k (sns (b)(4)), cl-325-10-k (sns (b)(4)).
 
Event or Problem Description
The patient was implanted on (b)(6) 2017 with four cortical strip leads which were secured to the dura with sutures; a rns neurostimulator was never implanted.On (b)(6) 2018 the leads were explanted to treat an 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 Key7853759
Report Number3004426659-2018-00030
Device Sequence Number13742092
Product Code PFN
UDI-Device Identifier00855547005052
UDI-Public010085554700505217171105
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 Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/05/2018
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 NumberCL-335-10-K
Device Catalogue Number1007610
Device Lot Number19368-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/10/2018
Initial Report FDA Received Date09/06/2018
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 Age9 YR
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