MAUDE Adverse Event Report: NEUROPACE NEUROPACE RNS SYSTEM; IMPLANTED BRAIN STIMULATOR FOR EPILEPSY

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 03/30/2018

Event Type  Injury  

Event Description

Neuropace rns implanted (vcu health system) (b)(6) 2018.First event: tia (b)(6) 2018.Second event: device infection (coag neg staph) on (b)(6) 2018.Device explanted (b)(6) 2018; washout and craniectomy.Pt is currently on home iv abx (vanc tid) via picc x 6-8 weeks.Cranioplasty anticipated 10 weeks post explant.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: IMPLANTED BRAIN STIMULATOR FOR EPILEPSY
• Manufacturer (Section D): NEUROPACE
• MDR Report Key: 7457700
• MDR Text Key: 106616095
• Report Number: MW5076693
• Device Sequence Number: 1
• Product Code: PFN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 44 YR
• Patient Weight: 77