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 10/01/2018

Event Type  Injury  

Event Description

It was reported that the patient had been in a car accident a couple months ago and was not feeling that the lead is moving and is ¿just not right¿.The patient also reported having an increase in seizures and feeling that stimulation was going off more.The patient had seen her neurologist who confirmed that lead impedance was ok.The neurologist referred the patient for generator replacement and possibly a lead replacement due to the age of the lead.It was reported that the neurologist was unsure of the cause of these events but suspected that they were due to the car accident.Clinical notes were received and reported that a radiograph of the vns showed no anomalies.There is no indication that the migration of the lead is associated with the increased seizures.Therefore, the increase in seizures is reported in manufacturer report #1644487-2018-02380.No relevant surgical intervention is known to have occurred to date.No additional or relevant information has been received to date.

Event Description

Information was received that the patient's lead and generator were replaced.Lead impedance was reported to be normal pre-operatively.The explanted devices are not being returned by the explanting facility due to the facility's policies.No additional or relevant information has been received 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8190351
• MDR Text Key: 131181449
• Report Number: 1644487-2018-02381
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

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: 03/21/2008
• Device Model Number: 302-20
• Device Lot Number: 1008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 40 YR