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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 RNS-300M-K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 10/08/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The treating center informed the neuropace field clinical engineer the patient was undergoing rns system explant (neurostimulator and all leads) on (b)(6) 2018 due to infection.The treating center reported this as a deep incisional infection.The patient is currently being treated with iv vancomycin.No other details were 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 Key8048124
MDR Text Key126446583
Report Number3004426659-2018-00041
Device Sequence Number1
Product Code PFN
UDI-Device Identifier00855547005120
UDI-Public010085554700512017151103
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 Nurse
Type of Report Initial
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberRNS-300M-K
Device Catalogue Number1007603
Device Lot Number20034-1-1-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/08/2018
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; Required Intervention;
Patient Age35 YR
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