MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Headache (1880); Seizures (2063)

Event Date 01/09/2014

Event Type  malfunction  

Event Description

Clinic notes dated (b)(6) 2014 were received which indicate that the patient returned to the clinic for a consultation.Per the notes, since his last visit, the patient states he is experiencing increased seizures.The patient states that he no longer feels the vagal nerve stimulator when it activates.The patient denies any injuries to the head or neck.The patient stated that a few weeks ago, he developed a left frontal headache and hoarseness.The patient is tolerating his medications well.Per the notes, the vns device was interrogated and diagnostics were performed.Diagnostics demonstrated high impedances and inability to output current.X-rays will be ordered to assess for lead fracture.Notes dated (b)(6) 2013 indicate the patient has been having about one seizure every three weeks.The patient reports this is due to the fact that he has been spacing out his medications due to the risk of running short.Notes dated (b)(6) 2013 indicate the patient was having difficulty affording his medication and cut back on his does.Subsequently, he had four seizures.The patient's vns generator was replaced on (b)(6) 2014.Attempts were made for additional information; however, they were unsuccessful.The explanted device will not be returned to the manufacturer, as it has been discarded.No additional information has been received in regards to these events.

Manufacturer Narrative

Device manufacturing records and programming history were reviewed.Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Describe event or problem, corrected data - the initial mdr inadvertently omitted that the lead was replaced.Date of explant, corrected data - the initial mdr inadvertently omitted that the lead was explanted (b)(4) 2014.

Event Description

The patient's vns generator and lead was replaced on (b)(6) 2014.

• Brand Name: LEAD MODEL 302
• 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: 3608421
• MDR Text Key: 4176287
• Report Number: 1644487-2014-00358
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2014
• Device Model Number: 302-20
• Device Lot Number: 201326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2009
• 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): Other
• Patient Age: 43 YR