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 Chest Pain (1776); Paralysis (1997); No Code Available (3191)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the patient that their generator pocket had ripped and the generator was lower than it should be following the patient lifting a heavy object.The patient reported that when they went under an overpass they believed the magnetic force of the wires in the overpass caused paralysis of their vocal cords, caused their lead wire to become taut, pain in neck, and their voice to become hoarse.The patient indicated that their neck was bruised and swollen from the stimulation that occurred due to the overpass and felt like their leads were going to come out of their neck.The surgeon's office indicated that the entirety of the reported adverse events experienced by the patient were related to the migration of the generator.It was reported that the generator was secured during initial implant surgery using a "butterfly wing" suture technique; however, the type of suture was not known.It was reported that the patient was referred for a pocket adjustment.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported by the patient that their vns generator stimulation was disabled; however, the disablement did not aid with their discomfort.No further relevant information has been received to date.

Event Description

Incoming communication from the patient indicated that the device was programmed back on.It was previously reported that it had been disabled.No further relevant information has been received to date.

Manufacturer Narrative

Report source.Corrected data: supplemental report 02 inadvertently did not indicate the report source.

Event Description

The patient underwent generator replacement surgery due to the reported migration and adverse events.In pre-op it was reported by the patient that their battery had shifted and the patient wanted a smaller battery, felt hers was too large.It was reported that the surgeon relocated the generator higher in the patient's left chest and sutured it in.The patient reported that adverse events re-occurred with the replacement generator; and therefore, suspect product likely the patient's implanted lead.The patient indicated that they were unable to lift their head up after replacement surgery and that their lead was tighter / pulling and the migration re-occurred.It was reported that the patient believed the lead to be pulling across their face and chest.The nurse and physician assessed that the adverse events were related to the placement of the device.The patient also reported the generator felt hot in her chest randomly (not with stimulation) required placing something over it to cool it down and felt the generator moving in her chest when lifting chin.The patient indicated the lead was sticking out of her neck under the skin, and that the generator was placed over her pectoral muscle underneath "only 1 or 2 layers of skin" and that the skin was thin enough that the generator could be seen when a flashlight was focused on it.The patient also reported that she felt the generator had a sharp edge facing toward her armpit, which pinched the patient causing bruising when she lifts her arm.Device diagnostics were reportedly within normal limits and the patient's parameters were reduced but the patient's symptoms did not resolve with settings change.No known relevant additional surgical intervention has occurred to date.The explant facility typically discards explanted products, therefore the return of the generator is not expected 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: 8562974
• MDR Text Key: 143523927
• Report Number: 1644487-2019-00824
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,Followup,Followup,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2018
• Device Model Number: 304-20
• Device Lot Number: 202932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2014
• 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: 45 YR