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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
Medical Device Problem Codes Break (1069); High impedance (1291)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/16/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Review of the device ecog and stimulation path impedance in pdms confirmed that the ecog data was consistent with a lead break.
 
Event or Problem Description
The patient had a depth lead removed and replaced on (b)(6) 2018.During a follow-up visit on (b)(6) 2018, it was noted that the left depth lead impedances were high.The treating clinician palpated the lead which produced artifact during real-time ecog recordings.A decision was made to replace the lead which demonstrated evidence of a possible lead break.The cause of the lead break is unknown.
 
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Brand Name
NEUROPACE RNS SYSTEM
Common Device Name
NEUROPACE RNS SYSTEM
Manufacturer (Section D)
NEUROPACE, INC.
455 n. bernardo ave.
mountain view CA 94043
MDR Report Key8160400
Report Number3004426659-2018-00047
Device Sequence Number11294393
Product Code PFN
UDI-Device Identifier00855547005014
UDI-Public010085554700501417191208
Combination Product (Y/N)N
PMA/510(K) Number
P100026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Model NumberDL-344-10-K
Device Catalogue Number1007607
Device Lot Number23087-1-1-1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/16/2018
Initial Report FDA Received Date12/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age30 YR
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