MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

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

Patient Problem No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Event Description

The patient's neurologist provided clinic notes for surgery referral indicating that the patient has some gagging with vns swipe, as well as increased prominence of lead in left side of neck, with some tenderness to palpation.The patient still feels vns stimulation.The lead was very superficial with a sharp edge protruding through but not piercing the skin.The patient has neck pain and it is a concern that there is migration of the lead laterally, as well as migration of the vns in the chest.It was questioned if the patient has encountered a loss of efficacy both with normal output current stimulation and the magnet swipe as the patient had experienced an increase in seizures.The neurologist followed up with an ent surgeon for an evaluation to assess the leads.Additional information was received from the neurologist stating that the cause of the lead protrusion, migration, dysphagia, increased seizures, loss of efficacy, and pain in the left neck was unknown.The patient was experiencing an increase in seizures that was below pre-vns levels.There were no factors such as trauma or manipulation that could have contributed to the events, and lead and generator migration as well as loss of efficacy were the contributing factors for the patient¿s surgery referral.The patient's gagging, protrusion and tenderness in the left neck were not contributing factors for the patient's surgery referral.The generator¿s most recent battery status was stated to not be at end of life.No other relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

The patient received a generator replacement and the generator was disposed of after surgery.There was no repositioning of the new generator and a new pocket was not created.No other relevant information has been received to date.No known surgical intervention for the lead has occurred to date.

• Brand Name: LEAD MODEL 302
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7490466
• MDR Text Key: 107468903
• Report Number: 1644487-2018-00732
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2005
• 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): Required Intervention
• Patient Age: 44 YR