MAUDE Adverse Event Report: LIVA NOVA USA, INC. LIVA NOVA SENTIVA MODEL 1000 GENERATOR; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number SENTIVA MODEL 1000

Device Problems Electromagnetic Interference (1194); Low impedance (2285); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 08/27/2020

Event Type  Injury  

Event Description

Patient with history of intractable epilepsy.Had vns placed in late 2019.Device was being adjusted and caused expected side effects of coughing and hoarseness.Patient asked to place supplied magnet over device to stop stimulation.The device could not be returned to the previous working order in clinic.Continued to give error of low impedance.Examined by neurologist, myself and liva nova representative.According to engineers fault is due to a switch that becomes magnetized and does not return to original position.Patient required surgery to replace the device.Unclear whether company will issue a refund for device.According to company this is a known fault that can happen due to magnetization of the generator.Fda safety report id# (b)(4).

• Brand Name: LIVA NOVA SENTIVA MODEL 1000 GENERATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVA NOVA USA, INC.
• MDR Report Key: 10487555
• MDR Text Key: 205668301
• Report Number: MW5096400
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SENTIVA MODEL 1000

Device Catalogue Number

• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 121