MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problems Fracture (1260); Device Contamination with Body Fluid (2317); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2022

Event Type  malfunction  

Event Description

It was reported that during pre-op for a routine generator replacement, high impedance was found.They did not have any prior knowledge of high impedance and is unknown if patient was experiencing any adverse events related to the high impedance.In surgery when the new generator was implanted, there was still high impedance.During surgery, surgeon found fluid in the conduit part of the lead and knew that would require a lead revision which he did not want to do on that day.The new battery was left in, but all parameters are at 0.Once the old battery was pulled out, the lead was noticeably coiled and a suture had broken.The representative noted that this patient had a lot of weight loss in the past year which most likely created extra room for the generator to move around which caused the lead to twist.The representative present at surgery later reported that the fluid was in the side tubing.Per the physician's assessment the generator did migrate due to the patient's recent weight loss.When the patient would bend over the device would flip.The generator was previously secured with a suture but this broke for an unknown reason.The surgeon said this was possibly related to patient's recent weight loss as well.The cause of the fluid leaks is unknown.The cause of the coiled lead was the flipping of device when bending over due to weight loss and suture coming undone.Although surgeon noted that the cause of fluid leaks is unknown, he also mentioned it was possibly due to the patient's weight loss.If patient's device was flipping around unsecured and caused coiled leads, it is most likely going to cause increased wear on the lead.The high impedance and fluid inside lead is most likely due to the generator migration, but cannot be concluded for certain.Facility is known to discard all explanted products therefore product return is not possible.No known additional relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.Medical device problem :(b)(4).

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15568383
• MDR Text Key: 301988291
• Report Number: 1644487-2022-01251
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/15/2018
• Device Model Number: 304-20
• Device Lot Number: 203049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2014
• 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 Age: 35 YR
• Patient Sex: Female