MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

Model Number 303-20

Device Problems Low impedance (2285); Electrical Shorting (2926)

Patient Problem Cough (4457)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

It was reported that the patient was seen in clinic and received a low impedance reading during interrogation.When asked if the patient could feel stimulation, it was reported they could since their mother could feel the patient coughing with stimulation.The device was then disabled.There has been no recent trauma to the implant site.No known 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.

• Brand Name: LEAD MODEL 303
• 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: 18311423
• MDR Text Key: 330465376
• Report Number: 1644487-2023-01788
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2011
• Device Model Number: 303-20
• Device Lot Number: 200285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2006
• 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): Other
• Patient Age: 22 YR
• Patient Sex: Female