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 Discomfort (2330)

Event Date 01/14/2022

Event Type  Injury  

Event Description

It was reported that a study patient has lower jaw and chin felt ¿numb and tingly" reported at the first post-op appointment.The patient has been experiencing tightness in the neck and is referred for surgery.No known surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

The patient presented to surgery to have her lead repositioned due to the feeling of ¿restriction¿ when turning her head.Pre-op diagnostics were normal.During the procedure, the surgeon freed up some excess lead near the generator and pushed more slack upwards cranially to give the patient more neck movement without feeling restriction or tightness.The patients head was turned after the lead was repositioned to test for any pulling or tension.There did not appear to be any.Post-op diagnostics were also normal.

Event Description

The lead needed to be repositioned because the wire was not long enough.There wasn't enough slack in the wire when it was implanted.Patient complained of it tugging/being too tight when she moved her head.

• 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: 14288262
• MDR Text Key: 290790809
• Report Number: 1644487-2022-00526
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/13/2022

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 Model Number: 304-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 05/11/2022; 09/21/2022; 12/08/2022
• Supplement Dates FDA Received: 06/02/2022; 10/14/2022; 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 39 YR
• Patient Sex: Female