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

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem Shock (2072)

Event Date 02/15/2016

Event Type  Injury  

Event Description

It was reported on (b)(4) 2016 that there is a possible malfunction with the patient's device although it is not clear what the issue is.It is known that the patient was reported for surgery.Further information clarified that there does not appear to be a generator malfunction or need to replace but there is a potential lead malfunction.Patient is getting shocking sensation with certain positions that coincide with stimulation.It was indicated that the suspected issue was only based on patient symptoms and not on actual diagnostic results at this point.Therefore, high impedance has not been confirmed.No further relevant information has been obtained to date.

Event Description

It was reported on 03/15/2016 that the patient is still having pain at several settings.The patient stated that x-rays were ordered to look at the device.

Event Description

Additional clinic notes were received for the patient.Notes dated (b)(6) 2015 mention that the patient is overall improved.On (b)(6) 2016, patient reports that within a few days of her last visit during which parameters were adjusted, she started experiencing left sided arm pain up to 3 times per day.Then about a week ago she started experiencing vocal gruffness and severe unilateral headaches.She put her magnet over her stimulator 3 days ago and symptoms resolved.Will adjust vns parameters first then medication if symptoms do not improve.Vns changed settings 2.5/25/130/60/3 minutes checked tolerability after 20 minutes and doing fine.(b)(6) 2016 notes, patient reports that she tried to tolerate increased does of vns but was unable and was seen last thursday and has pulse width reduced to 130.After walking out of appointment felt became hypomanic and started talking excessively.Since that time, she has up and down periods as well as considerable stress.Feels that the vns is now tolerable but feels her mood is unstable.She is still getting periodic shock feeling.Vns settings 2.5/25/130/60/3 minutes diagnostics lead impedance ok 2537 end of life 5-6 years / symptoms appear to have worsened somewhat around time of vns parameter changes.With increase in pw and decreasing output.Biggest problem today however is her mood changes which are unlikely from vns changes.(b)(6) 2016 and (b)(6) 2016 notes patient still with positional stimulating feel from vns.Referral to discuss with neurosurgery but no actual referral made.(b)(6) 2016 patient reports she is no longer getting shocking sensation in arm or pain in head.She reported tolerating well.(b)(6) 2016 notes, vns is doing fine and she is seeing md later apparently to check settings.Denies pain or complaints referable to vns, including mouth pain.Feels like it is keeping her mood positive and doesn¿t indicate that changes are required.Denies other physical complaints or side effects.

• 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: 5491142
• MDR Text Key: 40025756
• Report Number: 1644487-2016-00514
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 304-20
• Device Lot Number: 3866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/15/2016
• Initial Date FDA Received: 03/09/2016
• Supplement Dates Manufacturer Received: Not provided; 02/01/2021
• Supplement Dates FDA Received: 04/07/2016; 02/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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