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 Problems Scar Tissue (2060); Discomfort (2330); Neck Pain (2433); Implant Pain (4561)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via clinic notes that the patient started having a lot of pain at their vns site.The pain is associated with the turning of the head and neck and the patient feels tension.The vns was turned off, however the pain has not improved and the pain has gotten worse despite the vns being off.It was stated there appears to be scarring, and the lead is in tension from the neck to the chest.It was also noted the generator is in the chest loosely and can be flipped easily.The vns was interrogated and shows normal impedance.It was noted that the symptoms may stem from the fact that there is a lot of scarring which is putting the leads in tension and not allowing her to move her head comfortably.The physician believes the patient would benefit from a revision and exploration and untethering of the lead from the scar tissue as well as tacking the generator in place so it does not get flipped.Information was received that the patient's surgery has been completed - noting it to be a "lead clean-up".No devices were replaced.No additional relevant information has been received to date.

Manufacturer Narrative

Section d.Suspect medical device - 1.Brand name, 2.Type of device name, 4.Model #, serial #, lot #, expiration date (mo/day/yr), unique identifier #; corrected data: incorrect suspect product coded inadvertently on initial mdr section f10.Adverse event problem: health effect - clinical code; corrected data: e2311 inadvertently not included on initial mdr.Section h4.Device manufacture date (mo/day/yr); corrected data: incorrect suspect product manufacturing date inadvertently included on initial mdr.Section h6.Adverse event problem codes - investigation findings; corrected data: code c19 inadvertently not coded on initial mdr.

Event Description

Patient was reported to have a full revision due to their reported pain.

• 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: 12061704
• MDR Text Key: 258292731
• Report Number: 1644487-2021-00871
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Model Number: 304-20
• Device Lot Number: 204377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2018
• 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: 43 YR
• Patient Sex: Female