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 Pain (1994); Swelling (2091); Neck Pain (2433)

Event Date 03/10/2020

Event Type  Injury  

Event Description

It was reported that patent was having pain with stimulation in the back of her neck.It was noted that diagnostics were performed and were within normal limits.Per the call, the device was disabled and the pain went away and returned when the device was back on.The settings were lowered but the patient continued to have painful stimulation.Patient was disabled and referred for lead revision.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Additional information was received from physician that the painful stimulation is related to vns stimulation.The lead revision is for patient comfort.No lead fracture has been confirmed and is only suspected due to the adverse events the patient is having, however lead impedance is within normal limits showing there is no device malfunction.Clinic notes for the patient were received and reviewed.Within notes patient reported that she was experiencing pain across her forehead and neck pain.When the physician disabled device in clinic the forehead pain resolved but the neck pain still persisted.She now reports the pain is worse and some swelling in also occurring.The physician does not suspect that the neck pain is related to the patient¿s seizures or vns stimulation.The physician is unsure if there is a mechanical issue with the vns lead.The x-rays did not reveal anything.The physician stated that the event could be musculoskeletal due to neck swelling.The vns was turned off as the patient had been concerned of a lead fracture.The settings were increased at the last visit and the patient denies any recent trauma.Settings were decreased until they were tolerable for the patient.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Additional information was received that patient had chest x-ray performed.The results showed the lead appearing to be intact however a portion of the lead was extending into the neck and was not included in the field of view on the chest x-ray.Physician assessed that lead revision was for patient comfort.No surgery has occurred to date.No additional relevant information has been received to date.

Event Description

Additional information was received that the patient's generator was explanted.The explanted generator will not be returned per hospital policy.No additional 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: 9941641
• MDR Text Key: 187070237
• Report Number: 1644487-2020-00581
• 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,Followup,Followup
• Report Date: 07/10/2020

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: 07/07/2014
• Device Model Number: 304-20
• Device Lot Number: 2727
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 04/13/2020; 05/20/2020; 06/15/2020
• Supplement Dates FDA Received: 05/07/2020; 06/10/2020; 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR