MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Dysphagia/ Odynophagia (1815); Paralysis (1997); Tissue Damage (2104); No Code Available (3191)

Event Date 02/25/2020

Event Type  Injury  

Event Description

It was reported that the patient had injury to her vocal cords during generator replacement surgery.The patient noted that she chokes when she drinks and has to have thickened liquids and her voice has been hoarse since the surgery.She has no trouble eating food and no significant weight loss.She was referred for laryngoscopy.No other relevant information has been received to date.

Event Description

Clinic notes were received which state that laryngoscopy revealed left vocal cord paralysis with some movement at the arytenoid after the patient's vns surgery.The physician recommended the patient use thickened liquids and turn the head to the left when swallowing.Patient later had vocal cord injection surgery.After the surgery, the patient did well for about a week but then started having trouble swallowing, decreased phonatory times, hoarseness, and coughing.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10207827
• MDR Text Key: 196934848
• Report Number: 1644487-2020-00864
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2022
• Device Model Number: 1000
• Device Lot Number: 205169
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR