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 Problem Edema (1820)

Event Date 09/07/2018

Event Type  Injury  

Event Description

It was reported that the patient had swelling in their neck since surgery that has not gone away.The patient¿s wife reported that the swelling is filled with fluid and is really mushy, and goes from collar bone to his neck.The patient¿s neurologist had determined the swelling was not related to vns stimulation.Per the patient¿s neurologist, the reason for the swelling was not known.The patient was referred for replacement of their lead.Attempts for information from the surgeon have been unsuccessful to date.Device history records were reviewed for the devices.The device was sterilized and passed all specifications prior to distribution.Surgery is likely but has not occurred to date.No additional or relevant information has been received to date.

Event Description

It was reported that the lead was replaced.The surgeon acknowledged that the lead wasn¿t placed accurately and was attached to some of the fibers of the sternocleidomastoid.The lead was discarded.No additional or 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: 8473236
• MDR Text Key: 140615746
• Report Number: 1644487-2019-00633
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/27/2022
• Device Model Number: 304-20
• Device Lot Number: 204567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• 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: 51 YR