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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-344-10-K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 04/04/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2019 the treating center reported that the area near the patient's right depth lead incision site appeared to be infected.On (b)(6) 2019 the depth lead was explanted.No other information was provided by the treating center.
 
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Brand Name
NEUROPACE RNS SYSTEM
Type of Device
NEUROPACE RNS SYSTEM
Manufacturer (Section D)
NEUROPACE, INC.
455 n. bernardo ave.
mountain view CA 94043
Manufacturer (Section G)
NEUROPACE, INC.
455 n. bernardo ave.
mountain view CA 94043
Manufacturer Contact
ramona gonis
455 n. bernardo ave.
mountain view, CA 94043
6502382788
MDR Report Key8570086
MDR Text Key143722653
Report Number3004426659-2019-00014
Device Sequence Number1
Product Code PFN
UDI-Device Identifier00855547005014
UDI-Public010085554700501417200425
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberDL-344-10-K
Device Catalogue Number1007607
Device Lot Number23792-1-1-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age65 YR
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