MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

Device Problem Fracture (1260)

Patient Problems Chest Pain (1776); No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2019

Event Type  malfunction  

Event Description

It was reported that high impedance was detected on the patient's generator.It was reported that the patient was not experiencing any adverse events related to the high impedance.The patient was referred for lead revision due to high impedance and prophylactic generator replacement.The physician reviewed patient's chest and neck x-rays and indicated there were no visible fractures present.X-rays were reviewed and the generator appeared to be placed in the upper left chest per labeling, feed thru wires were intact and the connector pin appeared to be fully inserted.It was unable to assess whether the lead wires were intact at the connector pin due to the quality of the image and contrast of the lead portion that was near the generator.Strain relief appeared to be placed per labeling with three tie downs visually present and in the visible portions of the lead there were no fractures or sharp angles observed.The presence of micro-fractures could not be ruled out; however, based on the images provided, there was no obvious cause for the reported high impedance identified.No known relevant surgical intervention has occurred to date.No further additional information has been received to date.

Event Description

It was reported that the patient underwent full revision of generator and leads due to the high impedance previously detected.It was reported that impedance was high in pre-op.In the or the physician attempted to re-insert the lead pin; however, the impedance was still high.Once the lead was revised the impedance was within normal limits.The physician removed the anchor tether/helices and lead leaving the electrodes on the nerve.It was reported that the patient stayed overnight due to pain related to the replacement surgery / stitches and the patient used their magnet to disable generator stimulation.The physician reportedly believes this pain was related to the vns revision surgery.The suspect product has not been received by the manufacturer for product analysis 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: 8744075
• MDR Text Key: 149505974
• Report Number: 1644487-2019-01233
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/04/2020
• Device Model Number: 304-20
• Device Lot Number: 204301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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: 47 YR