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

Model Number 304-20

Device Problem High impedance (1291)

Patient Problems Undesired Nerve Stimulation (1980); Convulsion, Clonic (2222); No Code Available (3191)

Event Date 09/06/2017

Event Type  malfunction  

Event Description

The patient reported feeling continuous stimulation from the vns.It was reported that the patient typically experiences voice alterations with stimulation, but with the onset of the continuous stimulation the patient's voice was reported as continually hoarse.Normal mode was disabled and the events persisted.Magnet mode was disabled and the issue resolved.Then normal mode was programmed back on and the patient's voice changed with the normal duty cycle, but no continuous stimulation was reported.Magnet mode was programmed back on and there were no issues until the patient swiped the magnet, and then the feeling of continuous stimulation returned.Programming data was reviewed for the patient.Events of high impedance (> 5300 ohms) were identified intermittently in the 25% change in impedance section of the stored data.The most recent diagnostics were within normal limits.A review of device history records for the lead shows that no unresolved non-conformances were found.No known surgical intervention has occurred to date.No additional information has been received to date.

Event Description

X-ray images with anterior/posterior and lateral views of the chest and a lateral view of the neck were received and reviewed.It could not be assessed if the connector pin was fully inserted based on the angles of the images provided.The feedthrough wires appeared to be intact.A portion of the lead was routed behind the generator.No apparent sharp angles or gross fractures were observed in the part of the lead visible in the images provided.Based on the images provided the cause of the high impedance could not be determined.The presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images.Per the physician, the cause of the continuous stimulation, high impedance, and voice alterations is unknown.No known surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

It was reported that the patient's mother continues to insist that they have not experienced benefit from vns.Last year they wanted explant and received counseled after which the duty cycle was reduced from 58% to 35%.The mother reports the patient has had 6 generalized tonic-clonic seizures, up from her baseline of 4 a month, and regardless have asked to turn the vns off in order to test the value of therapy.Physician agreed to turn it off and see the patient's response after 3 months.No additional relevant information has been received to date.No surgical intervention has been reported 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 9644033
• MDR Text Key: 183934614
• Report Number: 1644487-2020-00126
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/11/2020
• Device Model Number: 304-20
• Device Lot Number: 203767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 02/24/2020; 10/22/2021
• Supplement Dates FDA Received: 03/05/2020; 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• 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: 35 YR
• Patient Sex: Female