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 Neck Pain (2433); No Code Available (3191)

Event Date 02/14/2019

Event Type  Injury  

Event Description

It was initially reported that the patient has a bulge in the neck and that there was a concern or a possible tear in the lead wire.The patient was referred for surgery.There was no report or indication that the patient¿s vns was interrogated or system diagnostics were performed which resulted in a high impedance warning.No relevant surgical intervention is known to have occurred to date.No additional or relevant information has been received to date.

Event Description

The patient's generator and lead were replaced.Return of the suspect product is not expected.No further relevant information has been received to date.

Event Description

It was reported that battery status and impedance was good.The patient had discomfort at the site of the lead.The physician reported that the surgery was for patient comfort.The bulge was attribute to the patient being thin and losing weight.No known surgical intervention has occurred to date.No further 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
• 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: 8392854
• MDR Text Key: 137926581
• Report Number: 1644487-2019-00422
• 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,Followup
• Report Date: 07/23/2019

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: 12/17/2016
• Device Model Number: 304-20
• Device Lot Number: 3497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 05/22/2019; 06/28/2019
• Supplement Dates FDA Received: 06/13/2019; 07/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2012
• 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: 39 YR