MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problems Low impedance (2285); Electrical Shorting (2926); Naturally Worn (2988)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

F10 health effect, clinical code: code e2402 utilized; appropriate term ¿migration¿ is not available.(note that although migration is an available medical device problem code, in this report¿s context, the migration does not reflect a problem with the functionality or delivery of therapy of the device.Therefore, a device problem code does not adequately capture the patient¿s adverse event.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.

Event Description

It was initially reported that the patient was scheduled for a full revision.Follow-up with the patient's physician found that upon interrogation, low impedance was seen.An x-ray showed the lead had crossed over/ migrated.During the battery replacement surgery, there were many areas of abraded insulation of the lead in the area of crossover, so a full revision was performed.The patient's physician later reported that the cause of the lead migration is not related to patient manipulation, trauma, or not being secured properly during implant, but to "other." the cause of the abraded lead insulation is related to the age of the lead.The explanted devices were discarded and are not available for return to the manufacturer.No other relevant information has been received to date.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18418542
• MDR Text Key: 331599169
• Report Number: 1644487-2023-01864
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/06/2016
• Device Model Number: 304-20
• Device Lot Number: 3348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2012
• 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: 15 YR
• Patient Sex: Female