MAUDE Adverse Event Report: LIVANOVA USA, INC. VNS THERAPY SENTIVA; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number 1000

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Event Description

New vns battery implant plugged in to current vns leads.No signal, reading "eos - end of service".Information relayed to rep via phone who said this should not be the case for a brand new device.Instructed to disconnect and open another new battery, due to probable faulty device.No harm to patient.2nd device worked appropriately.Defective device taken to manager, (b)(4), and company rep (b)(4) made aware.Fda safety report id #: (b)(4).

• Brand Name: VNS THERAPY SENTIVA
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC. ; houston TX 77058
• MDR Report Key: 10122987
• MDR Text Key: 194703219
• Report Number: MW5094853
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• 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 Age: 2 YR