MAUDE Adverse Event Report: NEUROSPACE BRAIN NERVE STIMULATOR; IMPLANTED BRAIN STIMULATOR FOR EPILEPSY

Model Number RNS-320-4

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Information (3190)

Event Date 03/13/2019

Event Type  Injury  

Event Description

Pt received implant of brain nerve stimulator device.Device failed shortly after operation.Required return to operating room and new stimulator implanted.Fda safety report id# (b)(4).

• Brand Name: BRAIN NERVE STIMULATOR
• Type of Device: IMPLANTED BRAIN STIMULATOR FOR EPILEPSY
• Manufacturer (Section D): NEUROSPACE
• MDR Report Key: 8555747
• MDR Text Key: 143432184
• Report Number: MW5086215
• Device Sequence Number: 1
• Product Code: PFN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RNS-320-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 17 YR
• Patient Weight: 77