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); Edema (1820)

Event Date 12/28/2020

Event Type  Injury  

Event Description

Patient reported she had to go to the emergency room after her implant surgery because her throat swelled up and she couldn't swallow.She was told she had a knot and it had shifted her trachea.They kept her overnight so they could get the swelling down to make she didn't have any trouble breathing.Prednisone was administered.The swelling went down and she was discharged.The knot returned later in the day but disappeared after three rounds of prednisone.No other relevant information has been received to date.

Event Description

Information was received from the surgeon that the patient was feeling anxious about the surgery which likely contributed to her complaints of adverse events.He noted the patient was complaining of a lot of swelling, and he never saw any swelling but noted that it is normal to have some swelling post-op.He indicated that the swelling and trouble swallowing and breathing was likely due to the vns surgery.He noted that the patient did not appear to have any serious injuries.He noted there were no abnormalities with the patient's wounds, no draining or redness.No other relevant 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
• MDR Report Key: 11287890
• MDR Text Key: 230690234
• Report Number: 1644487-2021-00197
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: 03/24/2021

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 Model Number: 304-20
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR