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

Model Number 1007609

Device Problem Device Remains Activated (1525)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The implanted rns system consists of the following rns-300, sn (b)(4); cl-325-10k, sn (b)(4).Device remains implanted.

Event Description

The patient reported clusters seizures (more intense auras) and severe headache and was admitted into the emu on (b)(6) 2016.A ct scan was performed and the site observed an acute intraparenchymal hemorrhage in the right parietal lobe immediately superior to the most superior strip and adjacent to the prior craniotomy.An angiogram was performed that confirmed an arteriovenous (av) fistula on (b)(6) 2016 and she was taken back for a follow up angiogram on (b)(6) 2016 which no longer revealed the presence of the av fistula.The opinion of the surgeons was that the av fistula thrombosed on its own.The doctor is not taking any action at this time and follow up ct scan is planned for two weeks from now.The leads were implanted after phase ii intracranial monitoring ((b)(6) 2015) and the neurostimulator was implanted a month later ((b)(6) 2015) the rns system remains implanted and programmed for detection and treatment.

• 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: 5502864
• MDR Text Key: 40386469
• Report Number: 3004426659-2016-00007
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917180316
• 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: Physician
• Type of Report: Initial
• Report Date: 03/14/2016

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
• Device Operator: Physician
• Device Model Number: 1007609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/15/2016
• 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 Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR