MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

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

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

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Information was received stating new that the patient¿s mother was worried about her son.She reported that since having his lead and vns generator replaced the patient has had complications.His complications all started the day of his vns replacement.His voice was very hoarse and they can barely understand him.She did say it may be a little better now.He is coughing much more than he was prior to vns replacement.His cough has progressed to all day, and to the point he dry heaves, and gags.He had lung x-rays but the x-ray came back clear.No pneumonia or anything showing his cough is lung related.He is eating some but not much.She said she is more concerned that he isn¿t hardly able to drink anything.As soon as he drinks, eats, or moves neck, he is coughing, gagging or trying to aspirate.Additional information was received that the adverse events occurred regardless of stimulation being on or off and they all began post operation 2 days after.Anytime he drinks or eats, he begins to cough, like he¿s trying to aspirate.His settings post-op were put on initial settings at the request of neurologist.The device was programmed back on.Patient saw an ent and has vocal cord paralysis on his left side.Most likely cause is the vns procedure.No surgery has occurred to date.No additional information has been received to date.

Event Description

Information was received that the physician believes that the patient's low impedance [housed in manufacturer report # 1644487-2019-00845] may have contributed to the patient's low impedance however the patient's voice and swallowing complications only began post vns lead and generator replacement.The physician saw no change when the patients vns was turned off during a short period of time.No additional or relevant information has been received to date.

Event Description

Information was received that the patient was doing a little better but not a lot better, then 2 weeks ago.The physician had titrated his vns some to 0.25ma.Soon after, the patient started coughing really bad again, and he was so bad this past weekend, his mother had to take him to the er.It is believed that the vocal cord issue is possibly related to the vns settings or exacerbated by them.They have turned the vns off while in office before and there was no change.Although they always turned it back on before he leaves the office.The patient is going to have additional ent swallowing tests performed.The results showed that he was aspirating when swallowing.The ent believes he has some degree of voicebox paralysis due to the vns surgery and/or due to the vns stimulation.No additional information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8697126
• MDR Text Key: 147935398
• Report Number: 1644487-2019-01143
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2023
• Device Model Number: 304-20
• Device Lot Number: 201714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR