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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 10/16/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4) the rns system remains implanted and programmed for use.
 
Event Description
On 10/16/2020 it was reported that the patient experienced an infection with poor wound healing at the rns system incision site.Treatment included surgical intervention to flush and close the wound, picc line and oral antibiotics.Diagnosed as a superficial incisional infection.
 
Event Description
Update regarding patient status.
 
Manufacturer Narrative
(b)(4).The patient underwent explant of the rns neurostimulator and depth lead in response to the infection on (b)(6) 2021.Per the treating center, the diagnosis was revised to deep incisional infection.
 
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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
MDR Report Key10826437
MDR Text Key215944977
Report Number3004426659-2020-00053
Device Sequence Number1
Product Code PFN
UDI-Device Identifier00855547005366
UDI-Public010085554700536617210212
Combination Product (y/n)N
PMA/PMN Number
P100026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberRNS-320-K
Device Catalogue Number1007927
Device Lot Number29903-1-1-1
Date Manufacturer Received01/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly; Other;
Patient Age7 YR
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