MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number DL-330-3.5-K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage, Intraventricular (1892)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient was implanted with two rns system depth leads on (b)(6) 2018.Post-lead placement mri revealed an intraventricular hemorrhage in the left lateral ventricle from the left thalamic lead placement.Final intra-op mri sequences revealed stability of the hemorrhage.As a safety precaution, the neurosurgeon postponed the neurostimulator placement procedure.

Manufacturer Narrative

(b)(4).

Event Description

Correction to product lot number.

• 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 Key: 7974299
• MDR Text Key: 123987178
• Report Number: 3004426659-2018-00040
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005038
• UDI-Public: 010085554700503817191012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DL-330-3.5-K
• Device Catalogue Number: 1007604
• Device Lot Number: 22858-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2018
• 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 Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 29 YR