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

Model Number RNS NEUROSTIMULATOR

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); No Code Available (3191)

Event Date 05/12/2015

Event Type  No Answer Provided  

Event Description

Patient experienced an extended hospitalization post-implant of the rns neurostimulator and leads due to an episode of aphasia and psychosis.Two ct exams were performed and hemorrhage and infarct were ruled out.The patient has had prior left sided anterior temporal resection and pre-op patient neuropsychological baseline testing indicated that the patient was markedly abnormal.The patient has now returned to baseline state.No report of product malfunction.The rns neurostimulator and leads remain implanted for detection and treatment of epilepsy.

Manufacturer Narrative

(b)(4).The rns neurostimulator and leads remain implanted for detection and treatment of epilepsy.Udi number is (b)(4).Device remains implanted.

• 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: 4848788
• MDR Text Key: 17630936
• Report Number: 3004426659-2015-00002
• Device Sequence Number: 1
• Product Code: PFN
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS NEUROSTIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2015
• 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: 57 YR