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 Problem Tissue Breakdown (2681)

Event Date 01/19/2021

Event Type  Injury  

Event Description

It was reported that the patient is having pain in his neck which started after he used a cervical collar post surgery.X-rays were provided and the x-ray report noted "small radiopaque density at the skin surface near the stimulator wire is likely external to the patient", therefore it appears there may be some lead extrusion.Patient also reported a knot in his neck.Ap and lateral neck x-ray images and lateral chest image were reviewed.No sharp angles were observed in the lead.The lead was assessed for fractures and no gross fractures or discontinuities were noted.Based on the x-rays received, the cause of the pain cannot be confirmed.Note that 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.No other relevant information has been received to date.

Event Description

Information was received from the np that there is no extrusion of the lead.The cause of the pain was noted to be due to vns stimulation.No other relevant information has been received to date.

Event Description

The patient reported that his settings were decreased due to the painful stimulation, and he then had an increase in seizures (reported in mfr.Report #1644487-2021-00671).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
• MDR Report Key: 11287699
• MDR Text Key: 230555449
• Report Number: 1644487-2021-00194
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2021

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: 03/02/2024
• Device Model Number: 304-20
• Device Lot Number: 205241
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 03/01/2021; 04/22/2021
• Supplement Dates FDA Received: 03/25/2021; 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR