MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 100; GENERATOR

Model Number 100

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

Patient Problem Paralysis (1997)

Event Date 01/12/2000

Event Type  Injury  

Event Description

It was reported that the patient had lost their voice completely after vns implant.After a year of no voice, patient underwent vns removal surgery and later found out that vns wasn't put in correctly.Patient's voice issues resolved a week after vns explant.

Event Description

After the device was removed, the patient's voice mostly came back.No additional relevant information has been received.

• Brand Name: PULSE GEN MODEL 100
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8333909
• MDR Text Key: 135989247
• Report Number: 1644487-2019-00292
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2001
• Device Model Number: 100
• Device Lot Number: 30151C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR