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); Scarring (2061)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via clinic notes that the patient had pain in their neck and chest where the vns device was located.The patients mother reported that the vns lead in the neck was poking out to the point where it was visible, and was very painful for the patient.The patients mother also noted that when the patient had their previous vns replacement, the patient had small breasts and now has larger breasts and the generator seems to have moved up to her collarbone.However, clinic notes later state that the physician believes that the generator is in an appropriate location above the left breast.The patient's lead was noted to be tight as it crossed the clavicle and traveled up in the region of the vagus nerve in neck, and is painful for the patient to extend their neck.The physician noted that they believe the patient has grown from the generator pocket to the site where the electrode array was placed along the vagus nerve and that the connecting lead has scarred down and become super tight and painful.No surgical intervention has occurred to date.No additional intervention has occurred to date.

Event Description

Additional information was received from surgeon who will be revising lead.She does not know the cause of the lead pulling, scarring or protrusion that is occurring.The replacement surgery is occurring for patient comfort and to prevent any damage to lead due to how tight it is.She reported that other the replacement surgery no other intervention is planned.Additional information was received from physician who referred patient for lead revision.The cause of the scarring is due to wire being too tight.The cause of the lead being tight across patient¿s clavicle is due to patient physiology as the patient has grown.The physician reported that there is no lead protrusion.Intervention is being taken to replace device and lengthen leads as the generator is dead and leads are too short for patient now.Additional information was received that replacement and revision surgery occurred.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: 10095912
• MDR Text Key: 192385372
• Report Number: 1644487-2020-00730
• 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: 07/02/2020

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: 04/11/2015
• Device Model Number: 304-20
• Device Lot Number: 201736
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 06/10/2020
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR