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

Model Number 304-30

Device Problem Fracture (1260)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 03/19/2020

Event Type  malfunction  

Event Description

Patient experienced an asthma flare and violent coughing, not alleged against vns, and then reported constant stimulation and discomfort in their jaw/teeth.The patient's device was checked and high impedance was observed so the patient was referred for a lead revision.Until the patient is able to get a lead revision, they were prescribed medication to treat their seizures.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient underwent full revision surgery.The explanted products have not been received by product analysis 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: 9954158
• MDR Text Key: 188421556
• Report Number: 1644487-2020-00601
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2015
• Device Model Number: 304-30
• Device Lot Number: 201714
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 05/27/2020
• Supplement Dates FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR