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

Model Number 1007427

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

Patient Problem Unspecified Infection (1930)

Event Date 01/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient came to neurosurgical clinic on tuesday, (b)(6) 2016 for pre-op evaluation.Surgeon noted exposed area to be about the size of a nickel and neurostimulator could be seen.There were no obvious signs of infection.Surgeon ordered a bone scan to rule out osteomyelitis and results showed no osteomyelitis.Routine lab work including wbc and sed rate were within normal limits.Patient underwent explant of neurostimulator and ferrule on wednesday, (b)(6) 2016.Cortical strip lead and depth lead remain implanted.Patient will undergo re-implant of the neurostimulator and ferrule within the next three months.

• 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: 5447133
• MDR Text Key: 38598048
• Report Number: 3004426659-2016-00005
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• 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): Required Intervention
• Patient Age: 62 YR