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

Model Number 302-30

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 04/10/2017

Event Type  malfunction  

Event Description

It was reported that a patient was experiencing painful stimulation when the settings are increased.The physician suspected a lead fracture and planned to refer the patient for a full revision surgery as the generator was at near end of service.It was noted from a previous office visit in 2017 that in 2007, the patient had a fall that resulted in pain in the left chest area, which led to the physician turning off the patient's device.The device was turned back on in 2017 to settings that the patient could tolerate.Systems and normal diagnostics were performed, indicating no device malfunction or anomalies.The physician still suspected a lead fracture, though it was unclear why.No surgery has occurred to date.No further relevant information has been received to date.

Manufacturer Narrative

Corrected data: initial report inadvertently did not include diagnostic data from 2007.

Event Description

Follow-up with the physician indicated that painful stimulation was occurring in the left chest area when the magnet is swiped.It was asked why the lead fracture was suspected and if the fracture was suspected due to an observed impedance issue, and it was stated that the lead fracture was suspected due to the painful stimulation.No surgery has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that the patient was had been in and out of the hospital with increased seizures, and in 2018 it was reported that the patient may have had a lead fracture.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

• 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: 7490146
• MDR Text Key: 107475481
• Report Number: 1644487-2018-00731
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2008
• Device Model Number: 302-30
• Device Lot Number: 1239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2005
• 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