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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 1007603
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 07/21/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).Not returned.
 
Event Description
On (b)(6) 2016 patient was implanted with rns neurostimulator and two depth leads.On (b)(6) 2016 rns system was explanted in response to infection.The infection was described by the physician as a deep incisional infection.Patient presented with a headache and fever (104).Patient was placed on antibiotics vancomycin and meropenem) for 2 weeks.
 
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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 Key5855307
MDR Text Key51442458
Report Number3004426659-2016-00020
Device Sequence Number1
Product Code PFN
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 08/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model Number1007603
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/22/2016
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 Age26 YR
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