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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-320-K - FGI
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812)
Event Date 09/28/2023
Event Type  Injury  
Event Description
On (b)(6) 2023, the patient presented with drainage from the surgical incision site.During examination dehiscence at the incision site and exposure of the hardware was observed.Treatment involved a wound washout.The incision was fully opened and washed out with triple antibiotic solution.The patient was started on iv antibiotics based on wound cultures (cefepime, meropenem).The device remains implanted.This was diagnosed as a deep incisional infection.
 
Manufacturer Narrative
(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.
 
Event Description
On (b)(6) 2023, the patient presented with drainage from the surgical incision site.During examination dehiscence at the incision site and exposure of the hardware was observed.Treatment involved a wound washout.The incision was fully opened and washed out with triple antibiotic solution.The patient was started on iv antibiotics based on wound cultures (cefepime, meropenem).The device remains implanted.This was diagnosed as a deep incisional infection.Update: on (b)(6) 2023 the rns system (neurostimulator and two depth leads) was explanted to treat the recurring infection.
 
Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
 
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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
5108822607
MDR Report Key18173652
MDR Text Key328566422
Report Number3004426659-2023-00060
Device Sequence Number1
Product Code PFN
UDI-Device Identifier00855547005366
UDI-Public010085554700536617231207
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberRNS-320-K - FGI
Device Catalogue Number1008191
Device Lot Number33116-1-1-1
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2023
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) Other; Required Intervention; Hospitalization;
Patient Age38 YR
Patient SexFemale
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